Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study).

INTRODUCTION: Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care. METHODS AND ANALYSIS: This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5 months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12 months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Metro South Health HREC (HREC/2021/QMS/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hospital departments, participating organisations/clinical services, and university seminars, and communicated at community and consumer-led forums. TRIAL REGISTRATION NUMBER: ACTRN12622000025730.

The cost-effectiveness of germline BRCA testing-guided olaparib treatment in metastatic castration resistant prostate cancer.

BACKGROUND: Olaparib targets the DNA repair pathways and has revolutionized the management of metastatic castration resistant prostate cancer (mCRPC). Treatment with the drug should be guided by genetic testing; however, published economic evaluations did not consider olaparib and genetic testing as codependent technologies. This study aims to assess the cost-effectiveness of BRCA germline testing to inform olaparib treatment in mCRPC. METHODS: We conducted a cost-utility analysis of germline BRCA testing-guided olaparib treatment compared to standard care without testing from an Australian health payer perspective. The analysis applied a decision tree to indicate the germline testing or no testing strategy. A Markov multi-state transition approach was used for patients within each strategy. The model had a time horizon of 5 years. Costs and outcomes were discounted at an annual rate of 5 percent. Decision uncertainty was characterized using probabilistic and scenario analyses. RESULTS: Compared to standard care, BRCA testing-guided olaparib treatment was associated with an incremental cost of AU$7,841 and a gain of 0.06 quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) was AU$143,613 per QALY. The probability of BRCA testing-guided treatment being cost effective at a willingness-to-pay threshold of AU$100,000 per QALY was around 2 percent; however, the likelihood for cost-effectiveness increased to 66 percent if the price of olaparib was reduced by 30 percent. CONCLUSION: This is the first study to evaluate germline genetic testing and olaparib treatment as codependent technologies in mCRPC. Genetic testing-guided olaparib treatment may be cost-effective with significant discounts on olaparib pricing.

Embedding stakeholder preferences in setting priorities for health research: Using a discrete choice experiment to develop a multi-criteria tool for evaluating research proposals.

We determined weights for a multi-criteria tool for assessing the relative merits of clinical-trial research proposals, and investigated whether the weights vary across relevant stakeholder groups. A cross-sectional, adaptive discrete choice experiment using 1000minds online software was administered to consumers, researchers and funders affiliated with the Australian Clinical Trials Alliance (ACTA). We identified weights for four criteria-Appropriateness, Significance, Relevance, Feasibility-and their levels, representing their relative importance, so that research proposals can be scored between 0% (nil or very low merit) and 100% (very high merit). From 220 complete survey responses, the most important criterion was Appropriateness (adjusted for differences between stakeholder groups, mean weight 28.9%) and the least important was Feasibility (adjusted mean weight 19.5%). Consumers tended to weight Relevance more highly (2.7% points difference) and Feasibility less highly (3.1% points difference) than researchers. The research or grant writing experience of researchers or consumers was not associated with the weights. A multi-criteria tool for evaluating research proposals that reflects stakeholders' preferences was created. The tool can be used to assess the relative merits of clinical trial research proposals and rank them, to help identify the best proposals for funding.

A Narrative Review of Health Status and Healthcare Delivery in the Oil and Gas Industry: Impacts on Employees, Employers, and Local Communities.

Workers in the oil and gas industry are exposed to numerous health risks, ranging from poor health behaviours to the possibility of life-threatening injuries. Determining the most appropriate models of healthcare for the oil and gas industry is difficult, as strategies must be acceptable to multiple stakeholders, including employees, employers, and local communities. The purpose of this review was to broadly explore the health status and needs of workers in the oil and gas industry and healthcare delivery models relating to primary care and emergency responses. Database searches of PubMed, EMBASE, CINAHL, PsycINFO, and Scopus were conducted, as well as grey literature searches of Google, Google Scholar, and the International Association of Oil and Gas Producers website. Resource-sector workers, particularly those in 'fly-in fly-out' roles, are susceptible to poor health behaviours and a higher prevalence of mental health concerns than the general population. Evidence is generally supportive of organisation-led behaviour change and mental health-related interventions. Deficiencies in primary care received while on-site may lead workers to inappropriately use local health services. For the provision of emergency medical care, telehealth and telemedicine lead to favourable outcomes by improving patient health status and satisfaction and reducing the frequency of medical evacuations.

A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.

Data sharing is essential for promoting scientific discoveries and informed decision-making in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. However, despite these commitments, recent investigations indicate significant scope for improvements in data sharing by the pharmaceutical industry. Drawing on a decade of literature and policy developments, this article presents perspectives from a multidisciplinary team of researchers, clinicians, and consumers. The focus is on policy and process updates to the PhRMA/EFPIA 2013 data sharing commitments, aiming to enhance the sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries, and result publications from pharmaceutical industry-sponsored trials. The proposed updates provide clear recommendations regarding which data should be shared, when it should be shared, and under what conditions. The suggested improvements aim to develop a data sharing ecosystem that supports science and patient-centred care. Good data sharing principles require resources, time, and commitment. Notwithstanding these challenges, enhancing data sharing is necessary for efficient resource utilization, increased scientific collaboration, and better decision-making for patients and healthcare professionals.

Tele-dentistry, its trends, scope, and future framework in oral medicine; a scoping review during January 1999 to December 2021.

BACKGROUND: Tele-dentistry has been increasingly used for different purposes of visit, consultation, triage, screening, and training in oral medicine. This study aims to determine the main facilitators, barriers, and participants` viewpoints of applying tele-dentistry in oral medicine and develop a framework indicating the input, process, output, and feedback. METHOD: This was a scoping review conducted in 2022 applying Arksey and O'Malley (2005) approach. Four databases including ISI web of science, PubMed, Scopus, and ProQuest were searched from January 1999 to December 2021. Inclusion criteria consisted of all original and non-original articles (reviews, editorials, letters, comments, and book chapters), and dissertations in English with a full text electronic file. Excel2016 was used for descriptive quantitative analysis and MAXQDA version 10 was applied for qualitative thematic analysis. A thematic framework was developed customizing the results of the review in a virtual mini expert panel. RESULTS: Descriptive results show that among 59 included articles, 27 (46%) have addressed the various applications of tele-dentistry during COVID-19 pandemic in the field of oral medicine. From geographical distribution perspective, most of the papers were published in Brazil (n = 13)/ 22.03%, India (n = 7)/11.86% and USA (n = 6)/10.17%. Thematic analysis shows that seven main themes of "information", "skill", "human resource", 'technical", "administrative', 'financial', and 'training and education' are explored as facilitators. 'Individual', 'environmental', 'organizational', 'regulation', 'clinical', and 'technical barriers' are also identified as main barriers of tele-dentistry in oral medicine. CONCLUSION: According to the results for using tele-dentistry services in oral medicine, a diverse category of facilitators should be considered and at the same time, different barriers should be managed. Users` satisfaction and perceived usefulness of tele-dentistry as final outcomes can be increased considering the system`s feedback and applying facilitator incentives as well as decreasing the barriers.

Improved concordance of challenging human epidermal growth factor receptor 2 dual in-situ hybridisation cases with the use of a digital image analysis algorithm in breast cancer.

AIMS: Accurate assessment of human epidermal growth factor receptor 2 (HER2) expression by HER2 immunohistochemistry and in-situ hybridisation (ISH) is critical for the management of patients with breast cancer. The revised 2018 ASCO/CAP guidelines define 5 groups based on HER2 expression and copy number. Manual pathologist quantification by light microscopy of equivocal and less common HER2 ISH groups (groups 2-4) can be challenging, and there are no data on interobserver variability in reporting of these cases. We sought to determine whether a digital algorithm could improve interobserver variability in the assessment of difficult HER2 ISH cases. METHODS AND RESULTS: HER2 ISH was evaluated in a cohort enriched for less common HER2 patterns using standard light microscopy versus analysis of whole slide images using the Roche uPath HER2 dual ISH image analysis algorithm. Standard microscopy demonstrated significant interobserver variability with a Fleiss's kappa value of 0.471 (fair-moderate agreement) improving to 0.666 (moderate-good) with the use of the algorithm. For HER2 group designation (groups 1-5), there was poor-moderate reliability between pathologists by microscopy [intraclass correlation coefficient (ICC) = 0.526], improving to moderate-good agreement (ICC = 0.763) with the use of the algorithm. In subgroup analysis, the algorithm improved concordance particularly in groups 2, 4 and 5. Time to enumerate cases was also significantly reduced. CONCLUSION: This work demonstrates the potential of a digital image analysis algorithm to improve the concordance of pathologist HER2 amplification status reporting in less common HER2 groups. This has the potential to improve therapy selection and outcomes for patients with HER2-low and borderline HER2-amplified breast cancers.

Cost-utility analysis of a supervised exercise intervention for women with early-stage endometrial cancer.

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 in this population; however, it is unclear whether there is value for money in integrating exercise into cancer recovery care for women treated for EC. This paper assesses the long-term cost-effectiveness of a 12-week supervised exercise intervention, as compared with standard care, for women diagnosed with early-stage EC. METHOD: A cost-utility analysis was conducted from the Australian health system perspective for a time horizon of 5 years. A Markov cohort model was designed with six mutually exclusive health states: (i) no CVD, (ii) post-stroke, (iii) post-coronary heart disease (CHD), (iv) post-heart failure, (v) post-cancer recurrence, and (vi) death. The model was populated using the best available evidence. Costs and quality-adjusted life years (QALYs) were discounted at 5% annual rate. Uncertainty in the results was explored using one-way and probabilistic sensitivity analyses (PSA). RESULT: The incremental cost of supervised exercise versus standard care was AUD $358, and the incremental QALY was 0.0789, resulting in an incremental cost-effectiveness ratio (ICER) of AUD $5184 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 99.5%. CONCLUSION: This is the first economic evaluation of exercise after treatment for EC. The results suggest that exercise is cost-effective for Australian EC survivors. Given the compelling evidence, efforts could now focus on the implementation of exercise as part of cancer recovery care in Australia.

Cost-effectiveness analysis of human papillomavirus vaccines for the prevention of cervical cancer in India.

BACKGROUND: Human papillomavirus (HPV) vaccines represent an important strategic opportunity to prevent cervical cancer in low-middle income countries, such as India. The economic evaluation of HPV vaccines is crucial to inform public-health decisions; however, the scarce economic evaluations from India have focused on the value for money of bivalent vaccines and took a healthcare perspective. The aim of this study is to conduct a cost-effectiveness analysis of all available HPV vaccines in India. MATERIAL AND METHODS: The Papillomavirus Rapid Interface for Modelling and Economics (PRIME) model was used to evaluate the cost-effectiveness of HPV vaccination of 12-year-old girls in India, from both healthcare and societal perspectives. Cervical cancer cases, deaths averted and the incremental cost per Disability Adjusted Life Years (DALY) averted were reported as primary outcomes. Sensitivity analysis was undertaken to handle any uncertainty or variability in the results. RESULTS: Compared with no vaccination, the incremental cost per DALY averted was USD 362.78 for nonavalent vaccine, USD 393.16 for quadrivalent vaccine and USD 432.24 for bivalent vaccine from a healthcare perspective. From a societal perspective, the incremental cost per DALY averted was USD 334.28 for nonavalent vaccine, USD 364.67 for quadrivalent vaccine and USD 403.75 for bivalent vaccine. Assuming constant prices per dose for all vaccines, the nonavalent vaccine dominated both quadrivalent and bivalent vaccines, indicating that it is the more cost-effective strategy. CONCLUSION: Vaccinating girls against HPV is a cost-effective strategy to reduce the incidence of cervical cancer and mortality due to cervical cancer in India.

Guidelines for genetic testing in prostate cancer: a scoping review.

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.

Economic evaluation of exercise interventions for individuals with cancer: A systematic review.

While there is good evidence that exercise is an effective adjunct therapy to cancer care, little is known about its value for money. The aim of this systematic review is to explore the available evidence pertaining to the cost-effectiveness of exercise interventions following cancer. A search of eight online databases (CINAHL, the Cochrane Library (NHSEED), Econlit, Embase, PsycInfo, PubMed, Scopus, Web of science) was first conducted on 26 March 2021 and updated on 8 March 2022. Only economic evaluations with results in the form of incremental cost-effectiveness ratio (ICER) were included. The Consolidated Health Economics Evaluation Reporting Standards (CHEERS) was used to appraise the quality of reporting in the studies. The study protocol was registered in PROSPERO. Sixteen studies comprising seven (44%) cost-utility analyses (CUA), one (6%) cost-effectiveness analyses (CEA) and eight (50%) combined CUA and CEA were identified. These studies explored exercise in five cancer types (breast, colon, lung, prostate, and blood), with half (50%) in breast cancer. Seven studies (44%) adopted societal perspectives. Exercise interventions were found to be cost-effective in five of ten (50%) trial-based economic evaluations and in five of the six (83%) model-based economic evaluations. Most exercise interventions included were supervised, while close supervision and individualized exercise sessions incurred higher costs. Exercise interventions in cancer care are cost-effective for various cancer types despite considerable heterogeneity in exercise delivery and the type of analysis used for economic evaluation. There is clear value in using decision-analytic modelling to account for the long-term benefits of exercise in cancer care.

Results from a type two hybrid-effectiveness study to implement a preoperative anemia and iron deficiency screening, evaluation, and management pathway.

BACKGROUND: Implementation of pathways to screen surgical patients for preoperative anemia and iron deficiency remains limited. This study sought to measure the impact of a theoretically informed, bespoke change package on improving the uptake of a Preoperative Anemia and Iron Deficiency Screening, Evaluation, and Management Pathway. STUDY DESIGN AND METHODS: Pre-post interventional study using a type two hybrid-effectiveness design evaluated implementation. Four hundred (400) patient medical record reviews provided the dataset (200 pre- and 200-post implementation). The primary outcome measure was compliance with the pathway. Secondary outcome measures (clinical outcomes) were anemia on day of surgery, exposure to a red blood cell (RBC) transfusion, and hospital length of stay. Validated surveys facilitated data collection of implementation measures. Propensity score-adjusted analyses determined the effect of the intervention on clinical outcomes, and a cost analysis determined the economic impact. RESULTS: For the primary outcome, compliance improved significantly post-implementation (Odds Ratio 10.6 [95% CI 4.4-25.5] p < .000). In secondary outcomes, adjusted analyses point estimates showed clinical outcomes were slightly improved for anemia on day of surgery (Odds Ratio 0.792 [95% CI 0.5-1.3] p = .32), RBC transfusion (Odds Ratio 0.86 [95% CI 0.41-1.78] p = .69) and hospital length of stay (Hazard Ratio 0.96 [95% CI 0.77-1.18] p = .67), although these were not statistically significant. Cost savings of $13,340 per patient were realized. Implementation outcomes were favorable for acceptability, appropriateness, and feasibility. CONCLUSION: The change package significantly improved compliance. The absence of a statistically significant change in clinical outcomes may be because the study was powered to detect an improvement in compliance only. Further prospective studies with larger samples are needed. Cost savings of $13,340 per patient were achieved and the change package was viewed favorably.

A review of the cost-effectiveness of genetic testing for germline variants in familial cancer.

BACKGROUND: 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. OBJECTIVE: To systematically review economic evaluations on cost-effectiveness of germline testing in breast, ovarian, or colorectal cancer. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Approaches to prioritising research for clinical trial networks: a scoping review.

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.

Methodological Approaches to Cost-Effectiveness Analysis in Saudi Arabia: What Can We Learn? A Systematic Review.

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.

Exercise in preventing falls for men with prostate cancer: a modelled cost-utility analysis.

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.

Impact of a New Cost-Effectiveness Threshold Implementation on Cancer Formulary Decisions in Jordan.

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.

Impact of Clinical Pharmacy Services on Patient Management in the Chemotherapy Infusion Clinics: A 5-Year Study at a Comprehensive Cancer Center.

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.

Cost-effectiveness analysis of home-based rehabilitation compared to usual care for people with inoperable lung cancer.

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.

The perceptions of informal carers of older people with dementia about the role of their pharmacists.

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.