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Study Design. A before and after study cohort study. Objectives. The aim of this study was to examine changes in health care costs after multidisciplinary spine care in patients with complex chronic back pain (CBP), to analyze the predictive value of patient and disease characteristics on health care costs, and to study the potential impact of biases concerning the use of real world data. Summary of Background Data. Due to high direct and indirect societal costs of back pain there is a need for interventions that can assist in reducing the economic burden on patients and society. Methods. All patients referred to a university-based spine center insured at a major health care insurer in the Netherlands were invited. Personal and disease-related data were collected at baseline. Health care costs were retrieved from the health care insurer from 2 years before to 2 years after intervention. Repeated measures analysis of variances were calculated to study changes in health care costs after intervention. Multivariable regression analyses and cluster robust fixed effect models were applied to predict characteristics on health care costs. To study regression to the mean, a fixed effect model was calculated comparing 2 years before and 2 years post-intervention. Results. In total 428,158 declarations during 4.6 years were filed by 997 participants (128,666 considered CBP-related). CBP-related costs significantly increased during the intervention period and reduced 2 years after the intervention. Total health care costs kept rising. The intervention was associated with a 21% to 34% (P

ObjectiveTo explore factors behind inpatient admissions by high-cost users (HCUs) in pre-end-stage chronic kidney disease (CKD).DesignRetrospective analysis of CKD.QLD Registry and hospital admissions of the Queensland Government Department of Health recorded between 1 July 2011 and 30 June 2016.SettingQueensland public and private hospitals.Participants5096 individuals with CKD who consented to the CKD.QLD Registry via 1 of 11 participating sites.Main outcomesAssociations of HCU status with patient characteristics, pathways and diagnoses behind hospital admissions at 12 months.ResultsAge, advanced CKD, primary renal diagnosis, cardiovascular disease and hypertension were predictors of the high-cost outcome. HCUs were more likely than non-HCUs to be admitted by means of episode change (relative risk: 5.21; 95% CI 5.02 to 5.39), 30-day readmission (2.19; 2.13 to 2.25), scheduled readmission (1.29; 1.11 to 1.46) and emergency (1.07; 1.02 to 1.13), for diagnoses of the nervous (1.94; 1.74 to 2.15), circulatory (1.24; 1.14 to 1.34) and respiratory (1.2; 1.03 to 1.37) systems and other factors influencing health status (1.92; 1.74 to 2.09).ConclusionsThe high relevance of episode change and other factors influencing health status revealed that a substantial part of excess demand for inpatient care was associated with discordant conditions often linked to frailty, decline in psychological health and social vulnerability. This suggests that multidisciplinary models of care that aim to manage discordant comorbidities and address psychosocial determinants of health, such as renal supportive care, may play an important role in reducing inpatient admissions in this population.

ObjectivesTo measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare.SettingTen clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes.ParticipantsFrom 8 October 2019 to 11 December 2019, 184 patients, aged 18 or more, who were receiving or had received within the previous 3 months active anticancer treatment were enrolled, 108 (59%) females and 76 (41%) males.InterventionA 30-item prefinal questionnaire, previously developed within the qualitative tasks of the project, was administered, either electronically (n=115) or by paper sheet (n=69).Primary and secondary outcome measuresAccording to the protocol and the International Society for Pharmacoeconomics and Outcomes Research methodology, the final questionnaire was developed by mean of explanatory factor analysis and tested for reliability, internal consistency (Cronbach’s α test and item-total correlation) and stability of measurements over time (test–retest reliability by intraclass correlation coefficient and weighted Cohen’s kappa coefficient).ResultsAfter exploratory factor analysis, a score measuring FT (FT score) was identified, made by seven items dealing with outcomes of FT. The Cronbach’s alpha coefficient for the FT score was 0.87 and the item-total correlation coefficients ranged from 0.53 to 0.74. Further, nine single items representing possible determinants of FT were also retained in the final instrument. Test–retest analysis revealed a good internal validity of the FT score and of the 16 items retained in the final questionnaire.ConclusionsThe Patient-Reported Outcome for Fighting FInancial Toxicity (PROFFIT) instrument consists of 16 items and is the first reported instrument to assess FT of cancer developed in a country with a fully public healthcare system.Trial registration numberNCT03473379.

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.

The long-term effects of cancer on patient quality of life and its economic burden are important issues that need to be addressed. Therefore, it is critical to assess patient priorities and investigate the value proposition of clinical tests in this field. The minimally invasive liquid biopsy has attracted much attention because it allows serial sampling during cancer progression, and provides valuable biological information on the tumor biology and treatment response through the analysis of analytes in the blood, such as circulating tumor cells (CTCs). To introduce CTC analysis in daily clinical practice, it is still necessary to firmly establish its clinical benefits and extra value for clinical decision-making. A laboratory medicine value proposition of CTC medical applications can help to address these issues. In this review, we discuss the current evidence for a value proposition of CTC detection, isolation, and characterization using the available technologies, and we summarize the unmet requirements for the full integration of CTCs in the care pathway.

Established treatments for obsessive compulsive disorder (OCD) include cognitive behaviour therapy (CBT) and selective serotonin reuptake inhibitor (SSRI) medication. Combined treatment may outperform monotherapy, but few studies have investigated this. A total of 49 community-based adults with OCD were randomly assigned to CBT, SSRI, or SSRI+CBT. Sertraline (50-200 mg/day) was given as the SSRI for 52 weeks. A 16-h-manualized individual CBT was delivered over 8 weeks with four follow-up sessions. Assessors were 'blinded' to treatment allocation. A preliminary health economic evaluation was conducted. At week 16, combined treatment (n=13) was associated with the largest improvement, sertraline (n=7) the next largest and CBT (n=9) the smallest on the observed case analysis. The effect size (Cohen's d) comparing the improvement in Yale Brown Obsessive Compulsive Scale on CBT versus combined treatment was -0.39 and versus sertraline was -0.27. Between 16 and 52 weeks, the greatest clinical improvement was seen with sertraline, but participant discontinuation prevented reliable analysis. Compared with sertraline, the mean costs were higher for CBT and for combined treatment. The mean Quality Adjusted Life Year scores for sertraline were 0.1823 (95% confidence interval: 0.0447-0.3199) greater than for CBT and 0.1135 (95% confidence interval: 0.0290-0.2560), greater than for combined treatment. Combined treatment appeared the most clinically effective option, especially over CBT, but the advantages over SSRI monotherapy were not sustained beyond 16 weeks. SSRI monotherapy was the most cost-effective. A definitive study can and should be conducted.

The Infectious Diseases Society of Taiwan (IDST), the Hematology Society of Taiwan, the Taiwan Society of Blood and Marrow Transplantation, Medical Foundation in Memory of Dr. Deh-Lin Cheng, Foundation of Professor Wei-Chuan Hsieh for Infectious Diseases Research and Education, and CY Lee's Research Foundation for Pediatric Infectious Diseases and Vaccines cooperatively published this guideline for the use of antifungal agents in hematological patients with invasive fungal diseases (IFDs) in Taiwan. The guideline is the first one endorsed by IDST focusing on selection of antifungal strategies, including prophylaxis, empirical (or symptom-driven) and pre-emptive (or diagnostic-driven) strategy. We suggest a risk-adapted dynamic strategy and provide an algorithm to facilitate decision making in population level as well as for individual patient. Risk assessment and management accordingly is explicitly emphasized. In addition, we highlight the importance of diagnosis in each antifungal strategy among five elements of the antimicrobial stewardship (diagnosis, drug, dose, de-escalation and duration). The rationale, purpose, and key recommendations for the choice of antifungal strategy are summarized, with concise review of international guidelines or recommendation, key original articles and local epidemiology reports. We point out the interaction and influence between elements of recommendations and limitation of and gap between evidences and daily practice. The guideline balances the quality of evidence and feasibility of recommendation in clinical practice. Finally, this version introduces the concept of health economics and provides data translated from local disease burdens. All these contents hopefully facilitate transparency and accountability in medical decision-making, improvements in clinical care and health outcomes, and appropriateness of medical resource allocation.

AIM: To present the rationale, design and methodology of the GERAS project, which examines whether assessment of frailty and mild cognitive impairment could enhance risk prediction for biomedical, psychosocial outcomes and foster efficient resource allocation in kidney transplantation. BACKGROUND: For the burgeoning cohort of older patients considered for kidney transplantation, evidence gaps regarding frailty and mild cognitive impairment limit clinical decision-making and medical management. As known risk factors for 'hard' clinical outcomes in chronic illness, both require further study in transplantation. Integrating these and other bio-psychosocial factors into a comprehensive pre-transplant patient assessment will provide insights regarding economic implications and may improve risk prediction. DESIGN: A nation-wide multi-centre prospective cohort study nested in the Swiss Transplant Cohort Study. METHODS: Our nationally representative convenience sample includes 250 adult kidney transplant recipients. Data sources include the Swiss Transplant Cohort Study and primary data collected at time of transplantation, 6 months, 1 and 2 years post-transplant via established measures (the Montreal Cognitive Assessment, Psychosocial Questionnaire, Fried Frailty Instrument and a blood analysis), investigator-developed instruments and datasets compiled by hospitals' management control units, sickness funds, the Swiss Federal Statistical Office and the European Renal Association. Descriptive, competing risk survival and mixed effects analyses will be performed. Research Ethics Committee approval was obtained in January 2016. DISCUSSION: This pioneering project jointly examines frailty and mild cognitive impairment from bio-psychosocial and health economic perspectives. Results may significantly inform risk prediction, care tailoring and resource optimization to improve health outcomes in the ageing kidney transplant cohort. ispartof: Journal of Advanced Nursing vol:73 issue:3 pages:716-734 ispartof: location:England status: published

Objectives Sixty years ago, the Association of Osteosynthesis (AO) was founded with the aim to improve fracture treatment and has since grown into one of the largest medical associations worldwide. Aim of this study was to evaluate AO's impact on science, education, patient care and the MedTech business. Design/methods Impact evaluations were conducted as appropriate for the individual domains: Impact on science was measured by analyzing citation frequencies of publications promoted by AO. Impact on education was evaluated by analyzing the evolution of number and location of AO courses. Impact on patient care was evaluated with a health economic model analyzing cost changes and years of life gained through the introduction of osteosynthesis in 17 high-income countries (HICs). Impact on MedTech business was evaluated by analyzing sales data of AO-associated products. Results Thirty-five AO papers and 2 major AO textbooks are cited at remarkable frequencies in high ranking journals with up to 2000 citations/year. The number of AO courses steadily increased with a total of 645′000 participants, 20‘000 teaching days and 2‘500 volunteer faculty members so far. The introduction of osteosynthesis saved at least 925 billion Swiss Francs [CHF] in the 17 HICs analyzed and had an impact on avoiding premature deaths comparable to the use of antihypertensive drugs. AO-associated products generated sales of 55 billion CHF. Conclusion AO's impact on science, education, patient care, and the MedTech business was significant because AO addressed hitherto unmet needs by combining activities that mutually enriched and reinforced each other.

IntroductionIn order to properly evaluate the efficacy of orthopaedic procedures, rigorous, randomised controlled sham surgery trial designs are necessary. However, randomised controlled trials (RCTs) for surgery involving a placebo are ethically debated and difficult to conduct with many failing to reach their desired sample size and power. A review of the literature on barriers and enablers to recruitment, and patient and surgeon attitudes and preferences towards sham surgery trials, will help to determine the characteristics necessary for successful recruitment.Methods and analysisThis review will scope the diverse literature surrounding sham surgery trials with the aim of informing a discrete choice experiment to empirically test patient and surgeon preferences for different sham surgery trial designs. The scoping review will be conducted in accordance with the methodological framework described in Arksey and O’Malley (2005) and reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols extension for Scoping Reviews. The review will be informed by a systematic search of Medline, Embase, PsycInfo, CINAHL and EconLit databases (from database inception to 21 June 2019), a Google Scholar search, and hand searching of reference lists of relevant studies or reviews. Studies or opinion pieces that involve patient, surgeon or trial characteristics, which influence the decision to participate in a trial, will be included. Study selection will be carried out independently by two authors with discrepancies resolved by consensus among three authors. Data will be charted using a standardised form, and results tabulated and narratively summarised with reference to the research questions of the review.Ethics and disseminationThe findings from this review will inform the design of a discrete choice experiment around willingness to participate in surgical trials, the outcomes of which can inform decision and cost-effectiveness models of sham surgery RCTs. The qualitative information from this review will also inform patient-centred outcomes research. The review will be published in a peer-reviewed journal.Trial registration numberCRD42019133296.

Objectives Spinal muscular atrophy (SMA) has profound implications for patients and families. The aim of the present study was to gain insights into the effects caring for a child with SMA has on the costs incurred by families caring for a child with SMA from carer perspectives to identify gaps in provision of care, inform public policy and cost-effectiveness analyses. Design Interpretive phenomenological analysis guided the delivery and analysis of semi-structured interviews undertaken to explore the financial, opportunity and psychosocial costs associated with caring for children with SMA. Participants and setting Parents of children with SMA types II and III from a single Australian paediatric neuromuscular clinic participated in this study. Results A range of experiences were reported and information saturation (n=7) was reached endorsing themes, including: significant financial and caregiving burdens, adjusted career choices and limitations on career progression and a complex landscape of access to funding, equipment, support and resources. Opportunity costs of foregone employment, purchases and leisure activities were substantial, as were emotional and social impacts. Participants voiced determination and resilience, and called for continued efforts to improve supportive care services and resources. Conclusions The range and nature of costs met by families caring for a child with SMA were found to be expansive and not typically recognised. These include high direct costs associated with goods and services, indirect costs associated with voluntary care, substantial and long-term opportunities foregone in paid employment and career progression and unmeasured or hidden costs associated with mental health burden.

Background:Positive findings on early detection and early intervention services have been consistently reported from many different countries. The aim of this study, conducted within the European Brain Council project “The Value of Treatment”, was to estimate costs and the potential cost- savings associated with adopting these services within the context of the Czech mental health care reform.Methods:Czech epidemiological data, probabilities derived from meta-analyses, and data on costs of mental health services in the Czech Republic were used to populate a decision analytical model. From the health care and societal perspectives, costs associated with health care services and productivity lost were taken into account. One-way sensitivity analyses were conducted to explore the uncertainty around the key parameters.Results:It was estimated that annual costs associated with care as usual for people with the first episode of psychosis were as high as 46 million Euro in the Czech Republic 2016. These annual costs could be reduced by 25% if ED services were adopted, 33% if EI services were adopted, and 40% if both, ED and EI services, were adopted in the country. Cost-savings would be generated due to decreased hospitalisations and better employment outcomes in people with psychoses.Conclusions:Adopting early detection and early intervention services in mental health systems based on psychiatric hospitals and with limited access to acute and community care could generate considerable cost- savings. Although the results of this modelling study needs to be taken with caution, early detection and early intervention services are recommended for multi-centre pilot testing accompanied by full economic evaluation in the region of Central and Eastern Europe.

Antimicrobial resistance is a worldwide threat and a problem with large clinical and economic impact. Antimicrobial Stewardship Programs are a solution to curb resistance development. A problem of resistance is a separation of actions and consequences, financial and clinical. Such a separation makes it difficult to create support among stakeholders leading to a lack of sense of responsibility. To counteract the resistance development it is important to perform diagnostics and know how to interpret the results. One should see diagnostics, therapy and resistance as one single process. Within this process all involved stakeholders need to work together on a more institutional level. We suggest therefore a solution: combining diagnostics and therapy into one single financial product. Such a product should act as an incentive to perform correct diagnostics. It also makes it easier to cover the costs of an antimicrobial stewardship program, which is often overlooked. Finally, such a product involves all stakeholders in the process and does not lay the costs at one stakeholder and the benefits somewhere else, solving the misbalance that is present nowadays.

Breast cancer is a complex disease with heterogeneous presentation and clinical course. The last decade has witnessed the development, commercialization, and increasing use of multigene assays, designed to support physicians and patients in clinical decision making in early-stage breast cancer. These include Oncotype DX®, MammaPrint®, and Prosigna™ assays. The assays differ in the technological platforms used for assessment of gene expression, in the number of genes and in the specific genes that are being tested, in the patient populations used for their development and validation, and in their clinical utility. This review focuses on these three commercialized assays, their development, validation, and clinical utility. The review also addresses ongoing prospective trials investigating these assays and health-economic considerations relating to their use.

Health technology assessment (HTA) is the multidisciplinary field of policy analysis that studies medical, social, ethical, and economic implications of the development, diffusion, and use of health technologies. Its worldwide diffusion needs to be understood in the context of evidence-based healthcare delivery policy, and it is strongly driven by the search for new cost-containment policies by the governments of universal healthcare systems. This article presents the three main pillars of HTA: evaluating comparative effectiveness, cost-effectiveness, and organizational impact. While comparative analysis is more familiar to cardiologists, cost-effectiveness and organizational studies are less widely known because they expand the perspective of the evaluation to institutional settings and society at large and require significant inter-disciplinary work. Sound economic and organizational studies that extend comparative effectiveness studies may facilitate dialogue between medical science and policymaking. © The Author 2011.