Search

Background Genetic testing, to identify pathogenic or likely pathogenic variants in prostate cancer, is valuable in guiding treatment decisions for men with prostate cancer and to inform cancer prevention and early detection options for their immediate blood relatives. There are various guidelines and consensus statements for genetic testing in prostate cancer. Our aim is to review genetic testing recommendations across current guidelines and consensus statements and the level of evidence supporting those recommendations. Methods A scoping review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review (PRISMA-ScR) guidelines. Electronic database searches and manual searches of grey literature, including websites of key organisations were conducted. Using the Population, Concept, Context (PCC) framework, this scoping review included: men with prostate cancer or men at high risk of prostate cancer and their biological families; existing guidelines and consensus statements with supporting evidence for genetic testing of men with prostate cancer from any geographical location worldwide. Results Of the 660 citations identified, 23 guidelines and consensus statements met the inclusion criteria for the scoping review. Based on different levels of evidence about who should be tested and how, a diverse range of recommendations were identified. There was general consensus among the guidelines and consensus statements that men with metastatic disease be offered genetic testing; however, there was less consensus in relation to genetic testing in localised prostate cancer. While there was some consensus in relation to which genes to test, recommendations varied regarding who to test, testing methods and implementation. Conclusion While genetic testing in prostate cancer is routinely recommended and numerous guidelines exist, there is still considerable lack of consensus regarding who should be tested and how they should be tested. Further evidence is needed to inform value-based genetic testing strategies for implementation in practice.

Introduction Men who receive androgen deprivation therapy (ADT) for prostate cancer (PCa) are a vulnerable falls population due to the side effects of treatment. The purpose of this paper is to determine the cost-effectiveness of exercise in preventing falls and fractures for this high-risk population in Australia. Methods A decision analytic model was constructed to evaluate the cost utility of an exercise intervention compared to usual care from a health system perspective. The intervention comprised two 1-h sessions of supervised exercise per week over 1 year for men with non-metastatic PCa receiving curative radiation therapy and ADT. A Markov model simulated the transition between five health states: (1) at risk of falling; (2) at recurrent risk of falling; (3) fracture (minor or major); (4) non-fracture injury (minor or major); and (5) death. Model inputs including transition probabilities and utility scores were obtained from published meta-analyses, and costs were drawn from Australian data sources (e.g. Medical Benefits Schedule). The model time horizon was 3 years, and costs and effects were discounted at 5% annual rate. Costs and quality-adjusted life years (QALYs) were aggregated and compared between the intervention and control to calculate incremental net monetary benefit (iNMB). Uncertainty in the results was explored using deterministic and probabilistic sensitivity analyses (PSA). Results At a willingness-to-pay of AU$50,000 per QALY, the exercise intervention dominated, as it was less costly and more effective than usual care. The iNMB was $3010 per patient. The PSA showed a 58% probability the intervention was cost-effective. Conclusion This is the first modelled economic evaluation of exercise for men with PCa. Our results suggest supervised exercise is cost-effective in reducing the risks of falls and fractures in this population.

COVID-19 is one of the worst pandemics in recent human history, causing huge health, economic, and psychosocial damage. Since the pandemic hit, several unsubstantiated claims regarding exposure, transmission and management have been disseminated. Misinformation and associated public confusion now extend to the COVID-19 vaccines, spanning from claims based on possible links between some vaccine types and rare blood clots, to baseless claims. As a result, the public's trust in COVID-19 vaccines has been eroded, fuelling an already troubling trend of vaccine hesitancy. As medication experts and the most accessible healthcare providers, pharmacists are well equipped with the required skills and knowledge to improve COVID-19 vaccine uptake by taking roles that range from dispelling myths, to providing reliable evidence-based information, through to vaccine administration. This paper discusses public hesitancy to COVID-19 vaccines, major contributing factors, and the role pharmacists can play in reducing hesitancy and increasing vaccine uptake.

Purpose Cardiovascular disease (CVD) is the leading cause of death after treatment for endometrial cancer (EC). There is clinical evidence that exercise significantly reduces the risks of CVD and cancer recurrence; however, it is unclear whether there is value for money of integrating exercise into clinical cancer care for women treated for EC. This study aims to assess the long-term cost-effectiveness of a 12-week supervised exercise intervention for women diagnosed with early-stage EC compared to standard care. Method A cost-utility analysis was conducted from the Australian health system perspective. A Markov cohort model was designed with six mutually exclusive health states: i) No CVD, ii) Post-stroke, iii) Post-coronary heart diseases (CHD), iv) Post-heart failure, v) Post-cancer recurrence, vi) Death. The model was populated using the best available evidence in the literature. The cohort was followed for a time horizon of 5 years. Costs and outcomes were discounted at 5% annual rate. The incremental cost-effectiveness ratio (ICER) and net monetary benefit were estimated. Decision uncertainty was characterised using univariate and probabilistic sensitivity analysis. Result The incremental cost of supervised exercise versus standard care was AUD $496 and the incremental QALY was 0.064, resulting in an ICER of AUD $9,148 per QALY gained. The likelihood that the supervised exercise intervention was cost-effective at a willingness-to-pay threshold of AUD $50,000 per QALY was 97.8%. Conclusion This is the first economic evaluation of exercise after treatment for EC. The results suggest that exercise is cost-effective in this population. Implications for Cancer Survivors Given the low uncertainty in the results, efforts should focus on implementation of exercise as part of clinical cancer care.

Rising prices of novel cancer medications are increasing the economic burden from cancer in Jordan, risking the ability of cancer patients to access lifesaving and life-extending treatments. Furthermore, in the absence of a national health technology assessment (HTA) framework, medication prices in Jordan are set based on manufacturers’ pricing considerations and not a value proposition. In response to these challenges, King Hussein Cancer Center (KHCC), the de facto national cancer institute, developed a first-in-country, cancer-specific, cost-effectiveness threshold (CET) to aid institutional decision makers in approving only cost-effective medications. Over the past 10 years, cost-effectiveness analyses based on this CET have led to the introduction of > 70% of requested novel cancer medications after manufacturers agreed to lower prices, beyond registration prices, to meet the CET. Future work is warranted to empirically derive a CET for Jordan to better guide reimbursement decisions.

Value-of-information analysis (VOI) is a decision-theoretic approach that is used to inform reimbursement decisions, optimise trial design and set research priorities. The application of VOI analysis for informing policy decisions in practice has been limited due, in part, to the perceived complexity associated with the calculation of VOI measures. Recent efforts have resulted in the development of efficient methods to estimate VOI measures and the development of user-friendly web-based tools to facilitate VOI calculations. We review the existing web-based tools including Sheffield Accelerated Value of Information (SAVI), the web interface to the BCEA (Bayesian Cost-Effectiveness Analysis) R package (BCEAweb), Rapid Assessment of Need for Evidence (RANE), and Value of Information for Cardiovascular Trials and Other Comparative Research (VICTOR). We describe what each tool is designed to do, the inputs they require, and the outputs they produce. Finally, we discuss how tools for VOI calculations might be improved in the future to facilitate the use of VOI analysis in practice.

Alana Delaforce,1– 3 Jed Duff,1,4 Judy Munday,3– 5 Shannon Farmer,6,7 Kristin Miller,2 Lynne Glover,2 Christopher Corney,2 Cameron Hurst,8 Gareth Ansell,2,9 Naadir Gutta,2,9 Haitham Tuffaha,10 Janet Hardy2,3 1School of Nursing and Midwifery, The University of Newcastle, Callaghan, NSW, Australia; 2Mater Health Services, South Brisbane, QLD, Australia; 3Mater Research Institute-UQ, South Brisbane, QLD, Australia; 4Centre for Healthcare Transformation/School of Nursing, Queensland University of Technology, Kelvin Grove, QLD, Australia; 5Faculty of Health and Sport Science, The University of Agder, Kristiansand, Norway; 6Department of Haematology, Royal Perth Hospital, Perth, Western Australia, Australia; 7Medical School and Division of Surgery, The University of Western Australia, Perth, Western Australia, Australia; 8QIMR Berghoffer Medical Research Institute, Brisbane, QLD, Australia; 9School of Clinical Medicine - Mater Clinical Unit, The University of Queensland, St Lucia, QLD, Australia; 10Centre for the Business and Economics of Health, The University of Queensland, St Lucia, QLD, AustraliaCorrespondence: Alana Delaforce Level 6, Duncombe Building, Mater Hospital Brisbane, South Brisbane, QLD, 4101, AustraliaTel +61 7 3163 2853Email alana.delaforce@mater.org.auIntroduction: Blood transfusions are a risk factor for increased morbidity, mortality, and length of hospital stay. Patient blood management guidelines provide guidance to reduce risk and improve patient outcomes. They outline steps to help prevent transfusions and considerations for when deciding to transfuse. One recommendation to prevent unnecessary transfusion is to optimize patients using Pre-operative Anemia and Iron Deficiency Screening, Evaluation and Management Pathways (PAIDSEM-P). The uptake of these recommendations is highly variable, and an effective approach to implementing them in a tailored and context-specific manner remains elusive.Method and Design: A mixed-methods, interventional study, using a type two-hybrid effectiveness-implementation design, will evaluate the impact of a change package to improve the uptake of PAIDSEM-P. The change package consists of the intervention (PAIDSEM-P) supported by theoretically informed implementation strategies. Pre- and post-implementation, retrospective health record reviews will determine the effect of the change package on provider outcomes, including compliance with guideline recommendations as measured by the proportion of patients who have the appropriate tests performed, and, if required, appropriate treatment and/or referrals. Patient outcomes will be measured by checking for any difference in the proportion of patients with anemia on the day of surgery and the proportion of patients who receive a blood transfusion during the peri-operative period. An economic evaluation will be conducted to compare health outcomes and costs. The feasibility, acceptability and appropriateness of the PAIDSEM-P will be assessed using a quantitative, validated survey to measure implementation outcomes.Discussion: Testing of implementation theory is required to advance understanding of what works, in what context, and the impact on implementation success. This study aims to evaluate the impact of a theoretically informed change package on improving the uptake of PAIDSEM-P. If successful, it will also provide a framework for health care facilities to follow when addressing other evidence-practice gaps.Keywords: patient blood management, implementation, anemia, iron deficiency, surgery

Background: Chemotherapy requires careful dosing and monitoring and is associated with numerous adverse events. There is limited data describing the impact of clinical pharmacists in the chemotherapy ambulatory setting. Objective: This study aimed to evaluate the impact of clinical pharmacy services on patient management in the adult chemotherapy infusion clinics. Methods: This was a 5-year retrospective study that utilized the pharmacy electronic documentation system to determine the type of interventions and adverse drug events (ADEs) reported by the clinical pharmacists in the chemotherapy infusion clinics. Interventions were described based on the type of intervention and medication involved. ADEs were evaluated based on the type of ADE, the suspected medication, and the required management. Results: During the study period, 3,279 interventions and 1,445 ADEs were reported. The most common interventions involved dose adjustments (51%), followed by addition (23%) or discontinuation (21%) of prescribed medications. Carboplatin (20%) and zoledronic acid (14%) were the most common medications that required pharmacist interventions. The most common types of ADEs were hematologic (22%) and infusion-related reactions (20%). Docetaxel was the most common medication associated with ADEs (20%). Among the reported ADEs, most required adding supportive care (44%), followed by adjusting chemotherapy doses (22%). Conclusion: Clinical pharmacy services at the chemotherapy infusion clinics play an important role in optimizing the chemotherapy regimens as well as identifying and managing ADEs. Future studies should be directed to measure the impact of these services on patient outcomes as well as, physicians and pharmacy operational workload and cost savings.

Active involvement of patients in planning, conducting, and disseminating research has been adopted by many organisations internationally, but the extent to which this occurs in surgical wound care is not evident. This scoping review aimed to identify how patients have been involved in surgical wound care research and the quality of its reporting. Full-text studies focused on preoperative and postoperative surgical wound care in the acute care setting, published in English between 2004 and 2019, were included in the review. Screening, data charting, and quality assessment were conducted by two reviewers independently, adjudicated by a third, and then reviewed by five others. Thematic analysis synthesised the findings. Of the eight included studies, seven explained the methods for patient involvement and five described aims related to patient involvement and commented on patient involvement in the discussion. None met all of the quality assessment criteria. Three themes emerged: involvement in modifying and refining research processes, connecting and balancing expert and patient views, and sharing personal insights. Recommendations to improve patient involvement in surgical wounds research include the following: using framework and tools to inform future research; training researcher and patients in their respective research roles; and ongoing monitoring of patient involvement.

Purpose: Androgen deprivation therapy (ADT) has broad application in the treatment of prostate cancer (PC) and is associated with numerous, debilitating adverse effects. Increasing use of ADT for PC, longer timeframe for treatment (increased uptake of PSA testing and earlier diagnosis), as well as improved survival and an ageing population, means patients can live for a considerable period of time on or after ADT, experiencing these adverse effects. A number of systematic reviews of adverse effects of ADT for PC exist; however, no single systematic review has previously examined the evidence for all adverse effects, including newer forms of ADT. Methods: A systematic review of existing systematic reviews of ADT for PC was conducted (2010–February 2019), as per Cochrane guidelines, to identify the highest level of risk/incidence evidence available, supplemented by evidence drawn from individual studies where no systematic review existed. Results: Incidence data was generated for 19 adverse effect subgroups, classified according to the common terminology criteria for adverse events (CTCAE). Conclusion: Incidence of adverse effects provides valuable information for future burden of disease studies. This information can better guide clinical management to reduce symptoms for patients and assist patients to make more informed decisions about their treatment, potentially improving disease outcomes. It also highlights the importance of supportive care for PC patients receiving ADT and their carers. For analysts conducting economic evaluations, the inclusion of adverse effects in PC decision analytic models can provide more comprehensive and accurate information for decision makers.

Targeted germline testing is recommended for those with or at risk of breast, ovarian, or colorectal cancer. The affordability of genetic sequencing has improved over the past decade, therefore the cost-effectiveness of testing for these cancers is worthy of reassessment. To systematically review economic evaluations on cost-effectiveness of germline testing in breast, ovarian, or colorectal cancer. A search of PubMed and Embase databases for cost-effectiveness studies on germline testing in breast, ovarian, or colorectal cancer, published between 1999 and May 2022. Synthesis of methodology, cost-effectiveness, and reporting (CHEERS checklist) was performed. The incremental cost-effectiveness ratios (ICERs; in 2021-adjusted US$) for germline testing versus the standard care option in hereditary breast or ovarian cancer (HBOC) across target settings were as follows: (1) population-wide testing: 344–2.5 million/QALY; (2) women with high-risk: dominant = 78,118/QALY, 8,337–59,708/LYG; (3) existing breast or ovarian cancer: 3,012–72,566/QALY, 39,835/LYG; and (4) metastatic breast cancer: 158,630/QALY. Likewise, ICERs of germline testing for colorectal cancer across settings were: (1) population-wide testing: 132,200/QALY, 1.1 million/LYG; (2) people with high-risk: 32,322–76,750/QALY, dominant = 353/LYG; and (3) patients with existing colorectal cancer: dominant = 54,122/QALY, 98,790–6.3 million/LYG. Key areas of underreporting were the inclusion of a health economic analysis plan (100% of HBOC and colorectal studies), engagement of patients and stakeholders (95.4% of HBOC, 100% of colorectal studies) and measurement of outcomes (18.2% HBOC, 38.9% of colorectal studies). Germline testing for HBOC was likely to be cost-effective across most settings, except when used as a co-dependent technology with the PARP inhibitor, olaparib in metastatic breast cancer. In colorectal cancer studies, testing was cost-effective in those with high-risk, but inconclusive in other settings. Cost-effectiveness was sensitive to the prevalence of tested variants, cost of testing, uptake, and benefits of prophylactic measures. Policy advice on germline testing should emphasize the importance of these factors in their recommendations. Breast, ovarian, prostate, and colorectal cancers are among the top causes of cancer related deaths. A substantial proportion of people with these cancers have inherited mutations. The identification of these gene abnormalities could provide people with opportunities to utilize preventive risk reduction surgeries or undertake frequent routine testing for these cancers. However, genetic testing requires healthcare resources and money. Previous reviews on the cost-effectiveness of genetic testing in familial cancers have concluded that targeted screening i.e., selective assessment of people at high-risk could justify the costs of testing. Our evaluation of economic studies in breast and ovarian cancer, however, suggests that genetic testing is cost-effective across a wide variety of situations starting from the screening of all healthy women above 30 years to the testing of women with existing breast or ovarian cancer. Testing in metastatic breast cancer to inform treatment with Olaparib, a drug known to selectively improve survival in people with genetic mutations, was the sole exception where testing was not cost-effective. Contrary to findings for breast or ovarian cancer, testing for colorectal cancer was cost-effective in people with high-risk i.e., family history but inconclusive in other situations. Evidence on the cost-effectiveness of testing in prostate cancer is lacking and as a result we were not able to provide advice in this cancer group.

Objective The recent establishment of the health technology assessment (HTA) entity in the Kingdom of Saudi Arabia (KSA) has resulted in increased interest in economic evaluation. The aim of this study is to evaluate the technical approaches used in published economic evaluations and the limitations reported by the authors of the respective studies that could affect the ability to perform economic evaluations in the KSA. Methods We conducted a systematic literature review of published economic evaluations performed for the KSA over the past 10 years. An electronic literature search of the PubMed, EMBASE, and Cochrane databases was performed. A CHEERS checklist was used to assess the quality of reporting. Reported limitations were classified into domains including the definition of perspectives, identification of comparators, estimation of costs and resources, and use of the incremental cost-effectiveness ratio threshold. Results Twelve evaluations were identified; most involved cost-effectiveness analysis (92%). Missing and unclear data were found within the CHEERS criteria. Regardless of the perspective used, most described the perspective as an “institutional” perspective (70%) and almost half were reclassified by the current reviewer (42%). Most did not clearly state the comparator (83%), and published model comparators were commonly used (50%). Resource estimation was mostly performed by the authors of the respective studies (67%), and costs were mostly obtained from hospital institutional data (75%). The lack of an established threshold for the country-specific willingness to pay was observed in 50% of the analyses. Conclusions Economic evaluations from the KSA are limited. Capacity building and country-specific HTA guidelines could improve the quality of evaluations to better inform decision making. Highlights Economic analysis of health technology should follow standard guidelines. Unfortunately, these guides are often underutilized, and our findings identify considerable missing, not clearly stated, or incomplete data within the analyses, which can weaken the impact of the recommendations. The limitations reported by the authors of the respective studies emphasize the suboptimal quality of the reporting. A lack of data was frequently identified and resulted in using “institutional” practice as a major source of data input for the analyses. In light of the call for the establishment of an HTA entity in the KSA, framing a standard analytic approach when conducting economic evaluations will support HTA in informing resource allocation decisions. We hope that our findings highlight the need for country-specific guidance to improve practice and enhance future research.

Objective: Few economic evaluations of lung cancer rehabilitation exist. The aim of this study was to assess the cost-effectiveness of providing home-based rehabilitation for inoperable lung cancer. Methods: A cost-utility analysis alongside a randomised controlled trial (RCT) of rehabilitation compared with usual care. The primary outcome was quality-adjusted life years (QALYs) gained. The incremental cost-effectiveness ratio [ICER (95% CI)] and the net monetary benefit are reported. Value of information (VOI) analysis assessed the need/value of more research. Results: Seventy participants (34 intervention and 36 usual care), average (SD) age 63.0 (12.0) years, 32 (45.7%) stage IV. The average intervention cost was AU$3421 (AU$5352 usual care), and effect (QALY) was 0.30 (0.31 usual care). The ICER was AU$228,197 (−1,173,194 to 1,101,450) per QALY gained. The net monetary benefit was AU$1508, favouring the intervention. The probability that the intervention was more cost-effective than usual care, at a willingness to pay threshold of AU$50,000, was 75%. VOI analysis showed that additional research to resolve decision uncertainty is potentially worthwhile. Conclusion: A high degree of uncertainty exists regarding the cost-effectiveness of lung cancer rehabilitation. Further RCTs, powered for economic evaluations and utilising rehabilitation sensitive outcomes, are required to support translation of evidence into clinical practice.

Background Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. Methods A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. Results Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution’s mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. Conclusion Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

This study aims to describe a protocol to develop a conceptual design for a technological device based on theoretical knowledge to improve medication adherence in people with dementia. The six steps of the intervention mapping approach will be systematically applied. Step 1 will be a needs assessment using a mixed-methods approach: a survey and interviews with carers to identify determinants of medication non-adherence. Device outcomes and objectives will be set in Step 2 followed by the selection of practical theory-informed methods in Step 3. In Step 4, the structure of the conceptual design will be determined through a Delphi technique. Finally, the implementation and evaluation plans for the design will be developed in Steps 5 and 6. To improve medication adherence in this population, the design should address the condition, patients’ and caregivers’ needs and factors contributing to the problem. Involvement of end-users and a multidisciplinary team will ensure a practical and fit-for-purpose design bridging the gap between research and practice.

Objective: Qualitative studies have elucidated cancer survivors' experiences of cognitive changes associated with cancer and cancer treatment. This study specifically explored experiences of women treated for breast cancer who were seeking cognitive rehabilitation. The objective was to characterise the frequency and nature of cognitive changes and adaptations to cognitive change reported by these participants to better understand treatment needs of this group. Method: Australian women who had completed primary treatments for breast cancer (surgery, chemotherapy, and/or radiotherapy) and volunteered to participate in one of two cognitive rehabilitation intervention studies were interviewed via telephone. Interview responses regarding cognitive changes and adaptations to cognitive change were transcribed by the interviewers, then coded and analysed by two researchers using content analysis. Results: Among the 95 participants (age M=54.3 years, SD=9.6), the most commonly reported cognitive change was memory (79% of participants) and 61% reported more than one type of cognitive change. Adaptations to change were reported by 87% of participants, with written or electronic cues the most common (51%). Most often, participants reported using a single type of adaptation (48%) with only 39% reporting multiple types of adaptations. Conclusions: Women treated for breast cancer, who were seeking cognitive rehabilitation, most commonly reported memory changes, which were mainly managed through a single type of adaptation. These results suggest that there is considerable scope for increasing the range of cognitive adaptations to improve the quality of life of cancer survivors who experience adverse cognitive changes.

Prostate cancer (PCa) patients with bone metastases tend to have significant functional impairment from long-term androgen deprivation therapy (ADT), exacerbated by subsequent treatments such as second-line hormone therapies (abiraterone and enzalutamide), first- and second-line chemotherapy or immunotherapies (Hart et al., 2017). They are at significant risk of falls, fractures and consequent hospitalisation. There is a growing body of evidence to support the effectiveness of exercise in addressing the adverse effects of advanced PCa treatment (Hayes et al., 2019). Despite recommendations for men with bone metastases to participate in supervised exercise, there is often a reticence on the part of clinicians and/or patients due to concerns of fragility fracture or other adverse effects (Hart et al., 2017). These men with significant treatment toxicity and a high disease burden are an important patient group for whom exercise has been demonstrated to improve quality of life (QoL) (Galvao et al., 2018). To inform policy and improve accessibility of exercise for advanced PCa patients, it is important to determine whether such interventions represent value for money.

Objectives As medication experts, pharmacists can play a significant role in helping people living with dementia and their informal carers make the best use of medications. However, little is known about this population’s needs and expectations of their pharmacists. The objective of this study was to report informal carers’ perceptions about the role of their pharmacists. Methods In a previous study, informal carers were interviewed to explore factors influencing medication adherence in older people living with dementia. The interview transcripts from the previous study were analysed thematically using an inductive approach to explore carers’ perceptions about the role of community pharmacists in helping carers and people living with dementia use medications as prescribed. Key findings The interviews of 20 informal carers were analysed. Carers were primarily females (85%), married (60%), completed university (60%) and unemployed (70%). The majority of care recipients had comorbidities (75%), and the number of medications ranged from 1 to 20. Three significant roles emerged: (1) provision of medication information, (2) advising on medication organisation and (3) conducting medication reviews. Conclusions Informal carers face several challenges in administering the medications to older people living with dementia. Pharmacists are expected to play a more active role in helping people living with dementia, and their carers make safe and effective use of medications.

To enhance early access to novel health technologies, reimbursement decisions are increasingly made when the evidence base to support those decisions is lacking or far from mature [1, 2]. Making decisions with substantial evidence uncertainty may lead to suboptimal recommendations and costly consequences (e.g. listing a drug that is not cost effective). Intuitively, decision uncertainty can be reduced by collecting more evidence; however, the additional benefits from a new research study may not justify its costs in terms of the direct research costs (e.g. site and recruitment costs) and the opportunity costs from the benefits forgone when the adoption of a promising health technology is deferred while the additional information is being collected [3, 4].

Prostate cancer (PCa) is the most commonly diagnosed cancer in Australia, accounting for one quarter of all new cancer diagnoses for males. Androgen deprivation therapy (ADT) is the standard first-line therapy for metastatic PCa but is also used across much of the spectrum of disease. Unfortunately, debilitating adverse effects are a significant and largely unavoidable feature of ADT. A recent systematic review of adverse effects of ADT identified 19 sub-groups classified according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The potential for multiple simultaneous adverse effects, their associated management and the impact of adverse effects on cancer outcomes and quality of life are important considerations in the treatment and supportive care of men with PCa. Exercise is increasingly being recognized as an efficacious strategy in managing these adverse effects. A rapid review was undertaken to examine the role of exercise in the management of the most commonly reported ADT adverse effects classified according to the CTCAE sub-groups. A systematic search was conducted in Medline, PsycINFO, Google Scholar and Google for the years 2010 to September 2019 to identify the benefits of exercise in managing the adverse effects of ADT for PCa. There is strong evidence for exercise as medicine in addressing several of the adverse effects of PCa such as loss of muscle mass and strength, fatigue and declining physical function. Moderate level evidence for PCa exists for exercise-induced improvements in depression and anxiety, bone loss, and sexual dysfunction. While evidence of the effectiveness of exercise is lacking for many adverse effects of ADT for PCa, evidence in the cancer population as a whole or other clinical populations is strong, and many clinical guidelines recommend exercise as a fundamental part of their clinical management. With the exception of gynaecomastia and breast pain, there is increasing evidence (PCa, cancer or other clinical populations) to suggest that exercise has the potential to reduce and even prevent many of the adverse effects of ADT, thus improving survivorship outcomes for men with PCa. Exercise has the potential to reduce and even prevent many of the adverse effects of ADT, thus improving survivorship outcomes for men with PCa. The use of exercise for PCa management has the potential to translate into health and economic benefits in improved quality of life and fewer complications, resulting in savings to the health care system, enhanced productivity and reduced patient and carer burden. Exercise thus has the potential to improve quality of life for this population as well as generate significant cost savings.

Background Exercise for prostate cancer (PCa) survivors has been shown to be effective in addressing metabolic function and associated co-morbidities, as well as sarcopenia and significant functional impairment resulting from long-term androgen deprivation. Evidence on the cost-effectiveness of exercise interventions for PCa, however, is lacking, thus the aim of this study was to determine the cost-effectiveness of a supervised exercise intervention for long-term PCa survivors who previously received radiation therapy and androgen-deprivation therapy. Methods Cost-effectiveness analysis from an Australian healthcare-payer perspective was conducted using patient-level data from a multicentre randomised controlled trial (RCT) of supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise in long-term PCa survivors (> 5 years post-diagnosis). Analysis was undertaken for the 6-month supervised exercise portion of the intervention, which involved 100 men aged between 62 and 85 years, 50 in each arm. The primary outcome was cost per quality-adjusted life-years (QALYs). Results A 6-month supervised exercise intervention for PCa survivors resulted in an incremental cost-effectiveness ratio of AU$64,235 (2018 AUD) at an incremental cost of AU$546 per person and a QALY gain of 0.0085. At a willingness-to-pay of AU$50,000, the probability that the intervention is cost-effective was 41%. Sensitivity analysis showed that maintenance of benefits via a 6-month home-based intervention, immediately following the supervised intervention, lowered the cost per QALY gained to AU$32,051. Discussion This is the first cost-effectiveness analysis of exercise for PCa survivors. The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY. It is likely that evidence to support cost savings from post-intervention outcomes would reveal greater benefits and contribute to a more comprehensive cost-effectiveness analysis. Future RCTs should incorporate longer follow-up durations and collection of data to support modelling to capture future health benefits. Measures of quality of life or utility more sensitive to the impact of physical activity would also improve future economic evaluations.

A substantial proportion of cancer patients experience heightened psychological distress that may include anxiety, depression, fear of cancer recurrence, and cancer‐specific distress.1, 2 Improving psychological outcomes of cancer patients across the continuum of care (ie, from diagnosis to survivorship) is a key aspect of oncology care, and as such there is an increasing expectation and requirement that cancer care service providers assess and address patients' psychosocial needs.3 These services vary in complexity depending on the level of psychosocial support required, care setting, and resource availability.4 There is a large body of evidence demonstrating the effectiveness of psychosocial care interventions in reducing depression and anxiety and improving quality of life of cancer patients.5-7 Nevertheless, and due to increasing health care costs, decision makers require evidence on the cost‐effectiveness (ie, value for money) of new services before they can make decisions to fund and implement them in practice. Economic evaluations are increasingly performed to generate evidence about the value for money of new health care interventions.

Objectives The aim of this study was to compare the listing success rates and time incurred to listing of recently approved lung cancer medications across Australia, Canada and England. Methods A comparison between the three countries was performed with respect to the listing status, time incurred for listing and differences in recommendations made for cost effectiveness. Major uncertainties and limitations that compromise health technology assessment (HTA) recommendations were identified. Results The listing success rate was found to be low across all three countries (33% Canada, 17% England and 8% Australia). Across the HTA agencies’ reviews, comparators were either dissimilar or altered for effectiveness and/or economic analysis. Overall, limited evidence was found for all indications, and uncertainties were identified due to indirect analyses (70%) and survival extrapolation (100%). Although most of the indications were concluded to be not cost effective, some were subsequently listed (47%) at a reduced price and/or with a specific access programme. Conclusions This study demonstrated a low listing success rate for novel lung therapies internationally within different HTA jurisdictions. Major uncertainties that are resistant to available solutions seem to be common across different countries; thus, international solutions would be beneficial

In 2010, the Australian Government introduced the managed entry scheme (MES) to improve patient access to subsidised drugs on the Pharmaceutical Benefits Scheme and enhance the quality of evidence provided to decision makers. The aim of this paper was to critically review the Australian MES experience. We performed a comprehensive review of publicly available Pharmaceutical Benefits Advisory Committee online documents from January 2010 to July 2017. Relevant information on each MES agreement was systematically extracted, including its rationale, the conditions that guided its implementation and its policy outcomes. We identified 11 drugs where an MES was considered. Most of the identified drugs (75%) were antineoplastic agents and the main uncertainty was the overall survival benefit. More than half of the MES proposals were made by sponsors and most of the schemes were considered after previous rejected/deferred submissions for reimbursement. An MES was not established in 8 of 11 drugs (73%) despite the high evidence uncertainty. Nevertheless, six of these eight drugs were listed after the sponsors reduced their prices. Three MESs were established and implemented by Deeds of Agreement. The three cases were concluded and the required data were submitted within the agreed time frames. The need for feasibility and value of an MES should be carefully considered by stakeholders before embarking on such an agreement. It is essential to engage major stakeholders, including patient representatives, in this process. The conditions governing MESs should be clear, transparent and balanced to address the expectations of various stakeholders.

When making funding decisions, research organisations largely consider the merits (e.g. scientific rigour and feasibility) of submitted research proposals; yet, there is often little or no reference to their value for money. This may be attributed to the challenges of assessing and integrating value of research into existing research prioritisation processes. We propose a framework that considers both the merits of research and its value for money to guide health research funding decisions. A practical framework is developed based on current processes followed by funding organizations for assessing investigator-initiated research proposals, and analytical methods for evaluating the expected value of research. We apply the analytical methods to estimate the expected return on investment of two real-world grant applications. The framework comprises four sequential steps: (1) initial screening of applications for eligibility and completeness; (2) merit assessment of eligible proposals; (3) estimating the expected value of research for the shortlisted proposals that pass the first two steps and ranking of proposals based on return on investment; and (4) selecting research proposals for funding. We demonstrate how the expected value for money can be efficiently estimated using certain information provided in funding applications. The proposed framework integrates value-for-money assessment into the existing research prioritisation processes. Considering value for money to inform research funding decisions is vital to achieve efficient utilisation of research budgets and maximise returns on research investments.

Purpose: To evaluate the cost-effectiveness of multiparametric magnetic resonance imaging (mpMRI) to diagnose prostate cancer and direct all low-risk patients into active surveillance (AS). Materials and Methods: A Markov cohort model was developed to assess three scenarios: 1) no mpMRI and current AS; 2) mpMRI and current AS; and 3) mpMRI and increased AS. Men were tracked from diagnosis to end-of-life. Estimates to populate the model were derived from systematic reviews, meta-analyses, epidemiological publications, and national cost reports. An Australian Government perspective was used. Outcomes included healthcare costs, survival, quality-adjusted life years (QALYs), number of biopsies, and significant and insignificant cancers. Extensive sensitivity analyses were undertaken to address possible variation in the modeled inputs. Results: Mean lifetime costs per patient were AU$23,191 for Scenario 1, AU$23,387 for Scenario 2 and AU$21,064 for Scenario 3. Corresponding QALYs were 7.81, 7.77, 7.83 for Scenarios 1, 2, and 3, respectively. At the current uptake of AS in Australia, mpMRI alone does not appear cost-effective (16.9% likelihood). However, mpMRI with AS for all men with low-risk disease is strongly cost-effective (86.9% likelihood) at a willingness-to-pay AU$50,000 per QALY gained. For the mpMRI options, for every 1000 men suspected of prostate cancer, using mpMRI would avoid 340 biopsies, detect an additional 20 significant cancers, and detect 10 fewer insignificant cancers. Conclusion: Diagnosis of prostate cancer through mpMRI technology would be cost-effective if it leads to increased uptake of AS for men with confirmed very-low- or low-risk prostate cancer. Level of Evidence: 2. J. MAGN. RESON. IMAGING 2017;45:1304–1315.

Objective: To describe the development, implementation, and outcomes of a structured research training program that aimed to increase the research productivity among hospital pharmacists. Methods: The program was conducted in a step-wise approach and started with educational sessions on evidence-based medicine and research methods. After about a year, pharmacists were trained and mentored on how to conduct and publish a research project. We evaluated the number of research projects and publications for the pharmacy department before and after the implementation of the program. Results: In the 5 years prior to implementing the program, there were a total of 4 institutional review board (IRB) proposals, 4 abstracts, and 2 manuscripts, which had pharmacists as primary investigators. After 5 years of running the program, there were 24 pharmacist-initiated research proposals submitted to the IRB, 29 abstracts, and 11 published manuscripts. The major challenges were the lack of sufficient time and the extensive training and mentorship required. Conclusion: Implementing a structured pharmacy research program at a hospital setting was feasible and was associated with an increase in the pharmacist-led research and publications. The success of such a program requires training and mentorship, strong commitment, and administrative support.

What is known and objective: Quetiapine is a second-generation antipsychotic that is commonly prescribed for a range of approved and off-label indications in older adults. However, little is known about its safety in this population. The available evidence on quetiapine safety is based on studies on second-generation antipsychotics as a group, often in the general population and for approved indications. There are no systematic reviews on the safety of quetiapine in older adults, and therefore, there is a need for systematically assessing quetiapine safety in this group of patients to establish an appropriate safety profile for this vulnerable population. The aim of this paper was to review and describe adverse drug events associated with quetiapine use in older adults.Methods: A systematic literature search was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Databases searched were CINAHL, PubMed, Medline, PsycInfo and the Cochrane Library.Results and discussion: Sixty-nine papers met the inclusion criteria. The majority of the studies (n=36, 52%) were observational, and 11 (16%) were randomized controlled trials (RCTs). Most of the reported indications (75%) were off-label. The most commonly reported adverse events were somnolence (25-39%), dizziness (15-27%), headache (10-23%), postural hypotension (6-18%) and weight gain (11-30%). From the included RCTs, comparing quetiapine with placebo, quetiapine resulted in significantly greater cognitive impairment, higher rates of falls and injury and increased mortality in patients with parkinsonism, but not in patients with dementia. Compared with risperidone and olanzapine, quetiapine had significantly lower risk of mortality, reduced rate of cerebrovascular events, increased rate of falls and injury and less metabolic disorders compared with olanzapine, but higher metabolic disorders compared with risperidone.What is new and conclusion: This work provides full characterization of quetiapine safety in older people, which may help healthcare providers better anticipate, prevent and manage ADEs in this population.

Summary Background Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. Methods We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. Findings Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference −4·5% [95% CI −11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (–2·7% [–9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with poplyurethane group (–1·2% [–7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. Interpretation Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. Funding Australian National Health and Medical Research Council.

PurposeTo evaluate the cost-effectiveness of BRCA testing in women with breast cancer, and cascade testing in family members of BRCA mutation carriers.MethodsA cost-effectiveness analysis was conducted using a cohort Markov model from a health-payer perspective. The model estimated the long-term benefits and costs of testing women with breast cancer who had at least a 10% pretest BRCA mutation probability, and the cascade testing of first- and second-degree relatives of women who test positive.ResultsCompared with no testing, BRCA testing of affected women resulted in an incremental cost per quality-adjusted life-year (QALY) gained of AU$18,900 (incremental cost AU$1,880; incremental QALY gain 0.10) with reductions of 0.04 breast and 0.01 ovarian cancer events. Testing affected women and cascade testing of family members resulted in an incremental cost per QALY gained of AU$9,500 compared with testing affected women only (incremental cost AU$665; incremental QALY gain 0.07) with additional reductions of 0.06 breast and 0.01 ovarian cancer events.ConclusionBRCA testing in women with breast cancer is cost-effective and is associated with reduced risk of cancer and improved survival. Extending testing to cover family members of affected women who test positive improves cost-effectiveness beyond restricting testing to affected women only.GENETICS in MEDICINE advance online publication, 4 January 2018; doi:10.1038/gim.2017.231.

Older people with dementia often depend on caregivers to manage their medications. The complexity of medication regimens in this population can impede medication adherence (i.e., taking medications as prescribed), which may compromise the effectiveness of treatment and increase the cost and burden of illness. Different technological devices have been used to improve medication adherence, however, these devices are often not evidence-based or designed with end-user involvement, thereby affecting their acceptability by people living with dementia and their caregivers. This in turn, can influence the effectiveness and uptake of such devices. This study aims to explore the challenges of medication adherence for both older people with dementia and their caregivers to guide the development of future technological solutions that can be effective, practical and sustainable.

Objective The aim of this study was to quantify the utilisation of vascular access devices in Queensland public hospitals and their associated cost. Methods Devices were broadly classified into peripheral intravenous catheters, central venous catheters and arterial lines. The number of catheters used was obtained from a central procurement department at Queensland Health and validated using Medicare Benefits Schedule (MBS) claims and/or hospital data from the Australian Institute of Health and Welfare for the same period. Resources consumed included equipment and staff time required to insert and remove catheters. Equipment costs were valued using negotiated hospital prices, and staff time was valued at the fixed industrial award wages in Australia or relevant MBS fees. Device maintenance costs (e.g. dressings) and costs of treating complications were excluded. Results Approximately 2.75 million vascular access devices were used in public hospitals in Queensland in 2016, at a total cost of A$59.14 million. This comprised a total equipment cost of around A$10.17 million and a total labour cost of A$48.85 million Conclusion Vascular access is an important component of healthcare expenditure. The present study is the first to characterise and cost vascular access devices in Queensland. Further research is needed on the costs of maintaining device function and of treating complications associated with vascular access. What is known about the topic? The cost of vascular access in Australia has previously been estimated from modelling, using various assumptions, or based on device utilisation in other countries. What does this paper add? For the first time, device utilisation for vascular access in Queensland has been quantified and costed. Results were obtained from reliable sources and validated against other databases. What are the implications for practitioners? Practitioners and managers may now provide accurate estimates about the cost of catheter failure, a potentially preventable problem that affects up to 50% of all catheters placed. Attaching costs to such failure may also stimulate research into how to reduce the problem.

Background: Older patients with dementia are often unable to take their medications as prescribed due to cognitive and physical impairment. Objectives: To review the evidence on medication adherence in older patients with dementia in terms of the level of adherence, outcomes, contributing factors, and available interventions. Methods: A systematic literature review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searched databases included CINAHL, Cochrane Library, DARE, MEDLINE, and PubMed. Results: Eighteen studies reported levels of medication adherence or discontinuation and related factors. Medication adherence ranged from 17% to 42%, and medication discontinuation before the end of treatment ranged from 37% to 80%. Nonadherence was associated with an increased risk of hospitalization or death, while increasing age, choice of medication, use of concomitant medications, and medicines’ costs were reported to decrease medication adherence. Telehealth home monitoring and treatment modification were the only interventions reported in the literature to improve medication adherence in this population. Conclusion: Older patients with dementia have a low level of medication adherence. Future research should focus on the development and implementation of interventions to help older patients with dementia and their caregivers make better use of medications.

Jordan is an Arab country located in the north of the Arabian Peninsula, west of Asia.1 It occupies an area of about 92 000 km2, with an estimated total population of about 9.5 million, most of whom reside in the capital, Amman. Jordan is renowned for its high-quality health care services and is considered one of the major destinations for medical tourism in the Middle East and North Africa region. This paper aims to describe current health care and pharmacy practice in Jordan. It is part of a series of invited papers on health care systems in countries around the world. The paper is structured according to the building blocks outlined in the World Health Organization’s Health Systems Framework.

Background: Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional information. Purpose: To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial. Methods: An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared. Results: Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%. Limitations: Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated. Conclusion: The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials.

Objectives: Olaparib can improve progression-free survival compared with chemotherapy in patients with a BRCA mutation and HER2-negative metastatic breast cancer (MBC); however, this drug comes at a high price (AU$6,900/pack). This study aims to evaluate the cost-effectiveness of olaparib in this population, and to use value of information (VOI) analysis to inform a potential risk-sharing agreement.