Rosanna Tarricone

Economic Evaluation for Devices and Drugs—Same or Different?

Although the general methods of economic evaluation are well established [1,2], it is often their detailed application that raises methodological challenges. Most international guidelines for economic evaluation, although appearing to be generic, have been written with pharmaceuticals in mind [3]. For example, they typically assume that randomized controlled trials (RCTs) will be available for the assessment of relative treatment effect. In this article, we argue that the economic evaluation of devices raises additional challenges that international guidelines frequently overlook.

Impact on Quality of Life of Urinary Incontinence and Overactive Bladder: A Systematic Literature Review

The paper provides a systematization of the scientific evidence on quality of life of patients affected by urinary incontinence (UI) and overactive bladder (OAB) through a systematic literature review. A single search strategy was performed through the databases and papers collected are reviewed by independent researchers finally, including 39 papers. A strong heterogeneity of studies emerged from the evidence. The multidimensionality of the consequences produced by UI and OAB increased the attention on the identification of the most affected dimension of life quality (i.e. physical, emotional) and on the attempt of predicting life quality impairment through specific variables.

Direct and indirect costs of schizophrenia in community psychiatric services in Italy: The GISIES study

Abstract Backround: The present work is a cost-of-illness (COI) study that aims at assessing total direct and indirect costs of schizophrenic patients in community psychiatric services in Italy and identifying the variables that influence costs. Methods: A retrospective prevalence-based multi-centre COI study, was designed. Ten community mental health centres (CMHC) were involved and 100 patients were recruited. Data on patients’ costs were gathered through specifically designed instruments. Results: More than half total direct costs was attributed to CMHC interventions. The yearly average costs of schizophrenia per patient amounted to nearly ITL 50 million: 30% for direct costs and 70% for indirect costs. Conclusion: CMHCs tend to manage long-term ill patients by adopting a strong community-based system of care. Schizophrenia is correlated to loss of working days and lack of well-being. From the results of this study, it might be argued that the de-institutionalisation programme has produced ‘spillovers’ in terms of families’ greater involvement in patients management.

Determinants of demand for total hip and knee arthroplasty: A systematic literature review

BackgroundDocumented age, gender, race and socio-economic disparities in total joint arthroplasty (TJA), suggest that those who need the surgery may not receive it, and present a challenge to explain the causes of unmet need. It is not clear whether doctors limit treatment opportunities to patients, nor is it known the effect that patient beliefs and expectations about the operation, including their paid work status and retirement plans, have on the decision to undergo TJA. Identifying socio-economic and other determinants of demand would inform the design of effective and efficient health policy. This review was conducted to identify the factors that lead patients in need to undergo TJA.MethodsAn electronic search of the Embase and Medline (Ovid) bibliographic databases conducted in September 2011 identified studies in the English language that reported on factors driving patients in need of hip or knee replacement to undergo surgery. The review included reports of elective surgery rates in eligible patients or, controlling for disease severity, in general subjects, and stated clinical experts’ and patients’ opinions on suitability for or willingness to undergo TJA. Quantitative and qualitative studies were reviewed, but quantitative studies involving fewer than 20 subjects were excluded. The quality of individual studies was assessed on the basis of study design (i.e., prospective versus retrospective), reporting of attrition, adjustment for and report of confounding effects, and reported measures of need (self-reported versus doctor-assessed). Reported estimates of effect on the probability of surgery from analyses adjusting for confounders were summarised in narrative form and synthesised in odds ratio (OR) forest plots for individual determinants.ResultsThe review included 26 quantitative studies−23 on individuals’ decisions or views on having the operation and three about health professionals’ opinions-and 10 qualitative studies. Ethnic and racial disparities in TJA use are associated with socio-economic access factors and expectations about the process and outcomes of surgery. In the United States, health insurance coverage affects demand, including that from the Medicare population, for whom having supplemental Medicaid coverage increases the likelihood of undergoing TJA. Patients with post-secondary education are more likely to demand hip or knee surgery than those without it (range of OR 0.87-2.38). Women are as willing to undergo surgery as men, but they are less likely to be offered surgery by specialists than men with the same need. There is considerable variation in patient demand with age, with distinct patterns for hip and knee. Paid employment appears to increase the chances of undergoing surgery, but no study was found that investigated the relationship between retirement plans and demand for TJA. There is evidence of substantial geographical variation in access to joint replacement within the territory covered by a public national health system, which is unlikely to be explained by differences in preference or unmeasured need alone. The literature tends to focus on associations, rather than testing of causal relationships, and is insufficient to assess the relative importance of determinants.ConclusionsPatients’ use of hip and knee replacement is a function of their socio-economic circumstances, which reinforce disparities by gender and race originating in the doctor-patient interaction. Willingness to undergo surgery declines steeply after the age of retirement, at the time some eligible patients may lower their expectations of health status achievement. There is some evidence that paid employment independently increases the likelihood of operation. The relative contribution of variations in surgical decision making to differential access across regions within countries deserves further research that controls for clinical need and patient lifestyle preferences, including retirement decisions. Evidence on this question will become increasingly relevant for service planning and policy design in societies with ageing populations.

The economic burden of stroke in Italy. The EcLIPSE Study: Economic Longitudinal Incidence-based Project for Stroke Evaluation.

Stroke is the second most common cause of death in the world. The aim of this study is to estimate stroke’s direct costs and productivity losses in Italy from a societal perspective and to explain cost variability. A prospective observational multicentre cost of illness study was designed. Four hundred and forty-nine consecutive patients admitted because of acute first-ever stroke in 11 Italian hospitals were enrolled. Costs and outcomes were assessed at patients’ enrolment, and at 3, 6 and 12 months after discharge. Overall, social costs in the first six months following the attack were € 11 600 per patient; 53% of this was health care costs, 39% non-health care costs and the remaining 8% productivity losses. Age, level of disability and type of hospital ward were the most significant predictors of six-month social costs. The acute phase counted for more than 50% of total health care costs, leaving the remaining 50% to the post-acute phase, indicating that follow-up should be on the agenda of policy makers also.

Prognostic Value of the Cell Cycle Progression Score in Patients with Prostate Cancer: A Systematic Review and Meta-analysis

CONTEXT The process of care for patients with prostate cancer is subject to different degrees of uncertainty. Patients and clinicians could, therefore, greatly benefit from improved prognostic instruments. One emerging tool is the cell cycle progression (CCP) score. OBJECTIVE This systematic review assesses evidence on the value of the CCP instrument in prostate cancer treatment by reviewing current publications and integrating the results via a meta-analysis. EVIDENCE ACQUISITION We performed a review of Medline and Embase in April 2014, according to Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA). Unpublished studies were retrieved from the 2013-2014 proceedings of major conferences in the field. Sixteen publications were selected for inclusion. EVIDENCE SYNTHESIS The results show that use of the CCP score is better than existing assessments at elucidating the aggressive potential of prostate cancer in an individual. The pooled hazard ratio for biochemical recurrence per 1-unit increase in the CCP score was 1.88 in a univariate model and 1.63 in a multivariate model. Four studies showed that CCP testing can impact the decisions of physicians regarding treatment, and potentially lead to a decrease in surgical interventions for low-risk patients. CONCLUSIONS This review offers a comprehensive overview of existing evidence on CCP testing, and provides clinicians, patients, and policy makers with a strong summary measure of its prognostic validity and clinical utility. It will be important to develop economic studies to measure the impact of such technology on health care systems. PATIENT SUMMARY In this paper, we review current evidence related to the cell cycle progression (CCP) score for patients with prostate cancer. We found good evidence suggesting that use of the CCP score improves prognosis, and can be a valuable tool for clinicians in treating patients. The economic benefits are yet to be studied.

Impact of chemotherapy-induced nausea and vomiting on health-related quality of life and resource utilization: A systematic review

BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) is a particularly distressing event for oncology patients. This review aims at analyzing the impact of CINV on Health-Related Quality of Life (QoL) and on the use of healthcare resources. METHODS A systematic search was conducted according to the PRISMA statement on MEDLINE, EMBASE and NHS EED. RESULTS Sixty-seven studies were included in the final selection. Despite the availability of numerous treatment options, CINV was found to have a strong impact on HRQoL of patients. Direct costs are particularly affected, but this result could be due to scarcity of studies assessing indirect costs. CONCLUSIONS Evidence supports the notion that CINV continues to have a negative impact on HRQoL of patients, even for those receiving moderately emetic chemotherapy. Further studies need also to collect data on the cost of CINV, particularly indirect costs, to ensure that decisions on use of healthcare resources are better supported.

Cost-effectiveness analysis for trigeminal neuralgia: Cyberknife vs microvascular decompression

Background/Aims We present the preliminary results of a cost-effectiveness analysis of cyberknife radiosurgery (CKR) versus microvascular decompression (MVD) for patients with medically unresponsive trigeminal neuralgia. Methods Direct healthcare costs from hospital’s perspective attributable to CKR and MVD were collected. Pain level caused by trigeminal neuralgia was measured through the Barrow Neurological Institute pain intensity scoring criteria, at admission and after an average of 6 months follow-up. Results 20 patients for both arms were enrolled, for a total of 40 patients. The two procedures resulted equally effective at 6 month follow-up, with different resources consumption: CKR reducing hospital costs by an average of 34% per patient. The robustness of these results was confirmed in appropriate sensitivity analyses. Conclusion CKR resulted to be a cost-saving alternative compared with the surgical intervention.

Hospital costs of central line-associated bloodstream infections and cost-effectiveness of closed vs. open infusion containers. The case of Intensive Care Units in Italy

ObjectivesThe aim was to evaluate direct health care costs of central line-associated bloodstream infections (CLABSI) and to calculate the cost-effectiveness ratio of closed fully collapsible plastic intravenous infusion containers vs. open (glass) infusion containers.MethodsA two-year, prospective case-control study was undertaken in four intensive care units in an Italian teaching hospital. Patients with CLABSI (cases) and patients without CLABSI (controls) were matched for admission departments, gender, age, and average severity of illness score. Costs were estimated according to micro-costing approach. In the cost effectiveness analysis, the cost component was assessed as the difference between production costs while effectiveness was measured by CLABSI rate (number of CLABSI per 1000 central line days) associated with the two infusion containers.ResultsA total of 43 cases of CLABSI were compared with 97 matched controls. The mean age of cases and controls was 62.1 and 66.6 years, respectively (p = 0.143); 56% of the cases and 57% of the controls were females (p = 0.922). The mean length of stay of cases and controls was 17.41 and 8.55 days, respectively (p < 0.001). Overall, the mean total costs of patients with and without CLABSI were € 18,241 and € 9,087, respectively (p < 0.001). On average, the extra cost for drugs was € 843 (p < 0.001), for supplies € 133 (p = 0.116), for lab tests € 171 (p < 0.001), and for specialist visits € 15 (p = 0.019). The mean extra cost for hospital stay (overhead) was € 7,180 (p < 0.001). The closed infusion container was a dominant strategy. It resulted in lower CLABSI rates (3.5 vs. 8.2 CLABSIs per 1000 central line days for closed vs. open infusion container) without any significant difference in total production costs. The higher acquisition cost of the closed infusion container was offset by savings incurred in other phases of production, especially waste management.ConclusionsCLABSI results in considerable and significant increase in utilization of hospital resources. Use of innovative technologies such as closed infusion containers can significantly reduce the incidence of healthcare acquired infection without posing additional burden on hospital budgets.

Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project

BackgroundQuality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as ‘cost-effectiveness analyses’. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity.ObjectivesThe main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making.MethodsAn experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula.ResultsObserved and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions.ConclusionsThis European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.