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.

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.

Adaptations to cognitive problems reported by breast cancer survivors seeking cognitive rehabilitation: A qualitative study.

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.

A Framework to Prioritise Health Research Proposals for Funding: Integrating Value for Money.

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.

Cost of vascular access devices in public hospitals in Queensland.

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 2.75million vascular access devices were used in public hospitals in Queensland in 2016, at a total cost of A$59.14million. This comprised a total equipment cost of around A$10.17million and a total labour cost of A$48.85million 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.

Directing research funds to the right research projects: a review of criteria used by research organisations in Australia in prioritising health research projects for funding.

OBJECTIVES: Healthcare budgets are limited, and therefore, research funds should be wisely allocated to ensure high-quality, useful and cost-effective research. We aimed to critically review the criteria considered by major Australian organisations in prioritising and selecting health research projects for funding. METHODS: We reviewed all grant schemes listed on the Australian Competitive Grants Register that were health-related, active in 2017 and with publicly available selection criteria on the funders' websites. Data extracted included scheme name, funding organisation, selection criteria and the relative weight assigned to each criterion. Selection criteria were grouped into five representative domains: relevance, appropriateness, significance, feasibility (including team quality) and cost-effectiveness (ie, value for money). RESULTS: Thirty-six schemes were included from 158 identified. One-half of the schemes were under the National Health and Medical Research Council. The most commonly used criteria were research team quality and capability (94%), research plan clarity (94%), scientific quality (92%) and research impact (92%). Criteria considered less commonly were existing knowledge (22%), fostering collaboration (22%), research environment (19%), value for money (14%), disease burden (8%) and ethical/moral considerations (3%). In terms of representative domains, relevance was considered in 72% of the schemes, appropriateness in 92%, significance in 94%, feasibility in 100% and cost-effectiveness in 17%. The relative weights for the selection criteria varied across schemes with 5%-30% for relevance, 20%-60% for each appropriateness and significance, 20%-75% for feasibility and 15%-33% for cost-effectiveness. CONCLUSIONS: In selecting research projects for funding, Australian research organisations focus largely on research appropriateness, significance and feasibility; however, value for money is most often overlooked. Research funding decisions should include an assessment of value for money in order to maximise return on research investment.

The Australian Managed Entry Scheme: Are We Getting it Right?

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.

Cost-effectiveness analysis of germ-line BRCA testing in women with breast cancer and cascade testing in family members of mutation carriers.

PURPOSE: To evaluate the cost-effectiveness of BRCA testing in women with breast cancer, and cascade testing in family members of BRCA mutation carriers. METHODS: A 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. RESULTS: Compared 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. CONCLUSION: BRCA 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.

Estimating the healthcare costs of treating prostate cancer in Australia: A Markov modelling analysis.

PURPOSE: To estimate the health system costs of prostate cancer by disease risk category and treatment type over 2016 to 2025 and to identify potential strategies to contain the cost increase. METHODS: A Markov cohort model was developed using clinical pathways from US prostate cancer guidelines and clinical expertise. Estimates of the probabilities of various treatments and outcomes and their unit costs were sourced from systematic reviews, meta-analyses, epidemiological publications and national cost reports. Estimated costs by stage of disease, by major treatments and by age at diagnosis were reported in 2016 US dollars. One-way and probabilistic sensitivity analyses assessed potential variation in the modeled costs. RESULTS: Australia-wide costs of prostate cancer were estimated at US$270.9 million in 2016 rising to US$384.3 million in 2025, an expected increase of 42%. Of this total increase, newly diagnosed low risk cases will contribute US$32.9 million, intermediate-risk US$56.8 million, high-risk US$53.3 million and advanced US$12.6 million. For men diagnosed at age 65 with low-risk disease, lifetime costs per patient were US$14,497 for surgery, US$19,665 for radiation therapies to the primary lesion, and US$9,234 for active surveillance. For intermediate- or high-risk disease, mean costs per patient were US$34,941 for surgery plus radiation and US$31,790 for androgen deprivation therapy plus radiation while advanced cancer therapies were at US$31,574 per patient. Additional costs for managing iatrogenic disease secondary to these treatments were excluded. CONCLUSION: Strategies for identifying patients early before cancers have spread are critical to contain the estimated 42% increase in costs over the next decade. Increased uptake of active surveillance would also lead to substantial cost-savings in the management of low-risk prostate cancer.

Cost-effectiveness analysis of multiparametric MRI with increased active surveillance for low-risk prostate cancer in Australia.

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.

Efficient Value of Information Calculation Using a Nonparametric Regression Approach: An Applied Perspective.

BACKGROUND: Value-of-information (VOI) analysis provides an analytical framework to assess whether obtaining additional evidence is worthwhile to reduce decision uncertainty. The reporting of VOI measures, particularly the expected value of perfect parameter information (EVPPI) and the expected value of sample information (EVSI), is limited because of the computational burden associated with typical two-level Monte-Carlo-based solution. Recently, a nonparametric regression approach was proposed that allows the estimation of multiparameter EVPPI and EVSI directly from a probabilistic sensitivity analysis sample. OBJECTIVES: To demonstrate the value of the nonparametric regression approach in calculating VOI measures in real-world cases and to compare its performance with the standard approach of the Monte-Carlo simulation. METHODS: We used the regression approach to calculate EVPPI and EVSI in two models, and compared the results with the estimates obtained via the standard Monte-Carlo simulation. RESULTS: The VOI values from the two approaches were very close; computation using the regression method, however, was faster. CONCLUSION: The nonparametric regression approach provides an efficient and easy-to-implement alternative for EVPPI and EVSI calculation in economic models.

Cost-effectiveness Analysis of Nutritional Support for the Prevention of Pressure Ulcers in High-Risk Hospitalized Patients.

OBJECTIVE: To evaluate the cost-effectiveness of nutritional support compared with standard care in preventing pressure ulcers (PrUs) in high-risk hospitalized patients. DESIGN: An economic model using data from a systematic literature review. A meta-analysis of randomized controlled trials on the efficacy of nutritional support in reducing the incidence of PrUs was conducted. PATIENTS: Modeled cohort of hospitalized patients at high risk of developing PrUs and malnutrition simulated during their hospital stay and up to 1 year. INTERVENTIONS: Standard care included PrU prevention strategies, such as redistribution surfaces, repositioning, and skin protection strategies, along with standard hospital diet. In addition to the standard care, the intervention group received nutritional support comprising patient education, nutrition goal setting, and the consumption of high-protein supplements. MAIN OUTCOMES MEASURES: The analysis was from a healthcare payer perspective. Key outcomes of the model included the average costs and quality-adjusted life years. Model results were tested in univariate sensitivity analyses, and decision uncertainty was characterized using a probabilistic sensitivity analysis. MAIN RESULTS: Compared with standard care, nutritional support was cost saving at AU $425 per patient and marginally more effective with an average 0.005 quality-adjusted life years gained. The probability of nutritional support being cost-effective was 87%. CONCLUSIONS: Nutritional support to prevent PrUs in high-risk hospitalized patients is cost-effective with substantial cost savings predicted. Hospitals should implement the recommendations from the current PrU practice guidelines and offer nutritional support to high-risk patients.

Value of Information Analysis Informing Adoption and Research Decisions in a Portfolio of Health Care Interventions.

Background: Value of information (VOI) analysis quantifies the value of additional research in reducing decision uncertainty. It addresses adoption and research decisions simultaneously by comparing the expected benefits and costs of research studies. Nevertheless, the application of this approach in practice remains limited. Objectives: To apply VOI analysis in health care interventions to guide adoption decisions, optimize trial design, and prioritize research. Methods: The analysis was from the perspective of Queensland Health, Australia. It included four interventions: clinically indicated catheter replacement, tissue adhesive for securing catheters, negative pressure wound therapy (NPWT) in caesarean sections, and nutritional support for preventing pressure ulcers. For each intervention, cost-effectiveness analysis was performed, decision uncertainty characterized, and VOI calculated using Monte Carlo simulations. The benefits and costs of additional research were considered together with the costs and consequences of acting now versus waiting for more information. All values are reported in 2014 Australian dollars (AU$). Results: All interventions were cost-effective, but with various levels of decision uncertainty. The current evidence is sufficient to support the adoption of clinically indicated catheter replacement. For the tissue adhesive, an additional study before adoption is worthwhile with a four-arm trial of 220 patients per arm. Additional research on NPWT before adoption is worthwhile with a two-arm trial of 200 patients per arm. Nutritional support should be adopted with a two-arm trial of 1200 patients per arm. Based on the expected net monetary benefits, the studies were ranked as follows: 1) NPWT (AU$1.2 million), 2) tissue adhesive (AU$0.3 milliion), and 3) nutritional support (AU$0.1 million). Conclusions: VOI analysis is a useful and practical approach to inform adoption and research decisions. Efforts should be focused on facilitating its integration into decision making frameworks.

Cost-utility analysis of negative pressure wound therapy in high-risk cesarean section wounds.

BACKGROUND: Obese women undergoing cesarean section are at increased risk of postoperative infection. There is growing interest in negative pressure wound therapy (NPWT) to prevent closed surgical incision complications including surgical site infection; however, the evidence on the effectiveness and cost-effectiveness of this technology is limited. The objective of this study was to evaluate the cost-effectiveness of NPWT compared with that of standard dressing in preventing surgical site infection in obese women undergoing elective cesarean section based on current evidence and to estimate the value and optimal design of additional research to study this technology. METHODS: The analysis was from the perspective of Queensland Health, Australia, using a decision model. Parameters were obtained from the published literature, a pilot clinical trial, and expert opinion. Monte Carlo simulation was performed to calculate the net monetary benefit, characterize decision uncertainty, and estimate the value of additional research. Comparing the expected monetary benefits and costs of alternative trial sample sizes informed the optimal future study design. RESULTS: The incremental net monetary benefit of NPWT was Australian dollars 70, indicating that NPWT is cost-effective compared with that of standard dressing. The probability of NPWT being cost-effective was 65%. The estimated value of additional research to resolve decision uncertainty would be Australian dollars 2.7 million. The optimal sample size of a future trial investigating the relative effectiveness of NPWT would be 200 patients per arm. CONCLUSIONS: Based on the current evidence, NPWT is cost-effective; however, there is high uncertainty surrounding the decision to adopt this technology. Additional research is worthwhile before implementation.

Cost-effectiveness and value of information analysis of nutritional support for preventing pressure ulcers in high-risk patients: implement now, research later.

BACKGROUND: Pressure ulcers are a major cause of mortality, morbidity, and increased healthcare cost. Nutritional support may reduce the incidence of pressure ulcers in hospitalised patients who are at risk of pressure ulcer and malnutrition. OBJECTIVES: To evaluate the cost-effectiveness of nutritional support in preventing pressure ulcers in high-risk hospitalised patients, and to assess the value of further research to inform the decision to implement this intervention using value of information analysis (VOI). METHODS: The analysis was from the perspective of Queensland Health, Australia using a decision model with evidence derived from a systematic review and meta-analysis. Resources were valued using 2014 prices and the time horizon of the analysis was one year. Monte Carlo simulation was used to estimate net monetary benefits (NB) and to calculate VOI measures. RESULTS: Compared with standard hospital diet, nutritional support was cost saving at AU$425 per patient, and more effective with an average 0.005 quality-adjusted life years (QALY) gained. At a willingness-to-pay of AU$50,000 per QALY, the incremental NB was AU$675 per patient, with a probability of 87 % that nutritional support is cost-effective. The expected value of perfect information was AU$5 million and the expected value of perfect parameter information was highest for the relative risk of developing a pressure ulcer at AU$2.5 million. For a future trial investigating the relative effectiveness of the interventions, the expected net benefit of research would be maximised at AU$100,000 with 1,200 patients in each arm if nutritional support was perfectly implemented. The opportunity cost of withholding the decision to implement the intervention until the results of the future study are available would be AU$14 million. CONCLUSIONS: Nutritional support is cost-effective in preventing pressure ulcers in high-risk hospitalised patients compared with standard diet. Future research to reduce decision uncertainty is worthwhile; however, given the opportunity losses associated with delaying the implementation, "implement and research" is the approach recommended for this intervention.

Novel technologies can provide effective dressing and securement for peripheral arterial catheters: A pilot randomised controlled trial in the operating theatre and the intensive care unit.

BACKGROUND: Peripheral arterial catheters are widely used in the care of intensive care patients for continuous blood pressure monitoring and blood sampling, yet failure - from dislodgement, accidental removal, and complications of phlebitis, pain, occlusion and infection - is common. While appropriate methods of dressing and securement are required to reduce these complications that cause failure, few studies have been conducted in this area. OBJECTIVES: To determine initial effectiveness of one dressing and two securement methods versus usual care, in minimising failure in peripheral arterial catheters. Feasibility objectives were considered successful if 90/120 patients (75%) received the study intervention and protocol correctly, and had ease and satisfaction scores for the study dressing and securement devices of ≥ 7 on Numerical Rating Scale scores 1-10. METHODS: In this single-site, four-arm, parallel, pilot randomised controlled trial, patients with arterial catheters, inserted in the operating theatre and admitted to the intensive care unit postoperatively, were randomly assigned to either one of the three treatment groups (bordered polyurethane dressing (n=30); a sutureless securement device (n=31); tissue adhesive (n=32)), or a control group (usual practice polyurethane dressing (not bordered) (n=30)). RESULTS: One hundred and twenty-three patients completed the trial. The primary outcome of catheter failure was 2/32 (6.3%) for tissue adhesive, 4/30 (13.3%) for bordered polyurethane, 5/31 (16.1%) for the sutureless securement device, and 6/30 (20%) for the control usual care polyurethane. Feasibility criteria were fulfilled. Cost analysis suggested that tissue adhesive was the most cost effective. CONCLUSIONS: The pilot trial showed that the novel technologies were at least as effective as the present method of a polyurethane dressing for dressing and securement of arterial catheters, and may be cost effective. The trial also provided evidence that a larger, multicentre trial would be feasible.

Value of information analysis optimizing future trial design from a pilot study on catheter securement devices.

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.

Value of information analysis in healthcare: a review of principles and applications.

BACKGROUND: Economic evaluations are increasingly utilized to inform decisions in healthcare; however, decisions remain uncertain when they are not based on adequate evidence. Value of information (VOI) analysis has been proposed as a systematic approach to measure decision uncertainty and assess whether there is sufficient evidence to support new technologies. SCOPE: The objective of this paper is to review the principles and applications of VOI analysis in healthcare. Relevant databases were systematically searched to identify VOI articles. The findings from the selected articles were summarized and narratively presented. FINDINGS: Various VOI methods have been developed and applied to inform decision-making, optimally designing research studies and setting research priorities. However, the application of this approach in healthcare remains limited due to technical and policy challenges. CONCLUSION: There is a need to create more awareness about VOI analysis, simplify its current methods, and align them with the needs of decision-making organizations.

Cost-effectiveness analysis of clinically indicated versus routine replacement of peripheral intravenous catheters.

BACKGROUND: Millions of peripheral intravenous catheters are used worldwide. The current guidelines recommend routine catheter replacement every 72-96 h. This practice requires increasing healthcare resource use. The clinically indicated catheter replacement strategy is proposed as an alternative. OBJECTIVES: To assess the cost effectiveness of clinically indicated versus routine replacement of peripheral intravenous catheters. METHODS: A cost-effectiveness analysis from the perspective of Queensland Health, Australia, was conducted alongside a randomized controlled trial. Adult patients with an intravenous catheter of expected use for longer than 4 days were randomly assigned to receive either clinically indicated replacement or third-day routine replacement. The primary outcome was phlebitis during catheterization or within 48 h after catheter removal. Resource use data were prospectively collected and valued (2010 prices). The incremental net monetary benefit was calculated with uncertainty characterized using bootstrap simulations. Additionally, value of information (VOI) and value of implementation analyses were performed. RESULTS: The clinically indicated replacement strategy was associated with a cost saving per patient of AU$7.60 (95% confidence interval [CI] 4.96-10.62) and a non-significant difference in the phlebitis rate of 0.41% (95% CI -1.33 to 2.15). The incremental net monetary benefit was AU$7.60 (95% CI 4.96-10.62). The expected VOI was zero, whereas the expected value of perfect implementation of the clinically indicated replacement strategy was approximately AU$5 million over 5 years. CONCLUSION: The clinically indicated catheter replacement strategy is cost saving compared with routine replacement. It is recommended that healthcare organizations consider changing to a policy whereby catheters are changed only if clinically indicated.