A Law and Economics Analysis of Lobbying Regulation Towards an optimal structure through the Cost Indicator Index

This research primarily represents a contribution to the lobbying regulation research arena. It introduces an index which for the first time attempts to measure the direct compliance costs of lobbying regulation. The Cost Indicator Index (CII) offers a brand new platform for qualitative and quantitative assessment of adopted lobbying laws and proposals of those laws, both in the comparative and the sui generis dimension. The CII is not just the only new tool introduced in the last decade, but it is the only tool available for comparative assessments of the costs of lobbying regulations. Beside the qualitative contribution, the research introduces an additional theoretical framework for complementary qualitative analysis of the lobbying laws. The Ninefold theory allows a more structured assessment and classification of lobbying regulations, both by indication of benefits and costs. Lastly, this research introduces the Cost-Benefit Labels (CBL). These labels might improve an ex-ante lobbying regulation impact assessment procedure, primarily in the sui generis perspective. In its final part, the research focuses on four South East European countries (Slovenia, Serbia, Montenegro and Macedonia), and for the first time brings them into the discussion and calculates their CPI and CII scores. The special focus of the application was on Serbia, whose proposal on the Law on Lobbying has been extensively analysed in qualitative and quantitative terms, taking into consideration specific political and economic circumstances of the country. Although the obtained results are of an indicative nature, the CII will probably find its place within the academic and policymaking arena, and will hopefully contribute to a better understanding of lobbying regulations worldwide.

A review of the cost effectiveness of bisphosphonates in the treatment of post-menopausal osteoporosis in Switzerland

The economic burden associated with osteoporosis is considerable. As such, cost-effectiveness analyses are important contributors to the diagnostic and therapeutic decision-making process. The aim of this study was to review the cost effectiveness of treating post-menopausal osteoporosis with bisphosphonates and identify the key factors that influence the cost effectiveness of such treatment in the Swiss setting. A systematic search of databases (MEDLINE, EMBASE and the Cochrane Library) was conducted to identify published literature on the cost effectiveness of bisphosphonates in post-menopausal osteoporosis in the Swiss setting. Outcomes were compared with similar studies in Western European countries. Three cost-effectiveness studies of bisphosphonates in this patient population were identified; all were from a healthcare payer perspective. Outcomes showed that, relative to no treatment, treatment with oral bisphosphonates was predicted to be cost saving for most women aged ≥70 years with osteoporosis or at least one risk factor for fracture, and cost effective for women aged ≥75 years without prior fracture when used as a component of a population-based screen-and-treat programme. Results were most sensitive to changes in fracture risk, cost of fractures, cost of treatment, nursing home admissions and adherence with treatment. Swiss results were generally comparable to those in other European settings. Assuming similar clinical efficacy, lowering treatment cost (through the use of price-reduced brand-name or generic drugs) and/or improving adherence should both contribute to further improving the cost effectiveness of bisphosphonates in women with post-menopausal osteoporosis. Published evidence indicates that bisphosphonates are estimated to be similarly cost effective or cost saving in most treatment scenarios of post-menopausal osteoporosis in Switzerland and in neighbouring European countries.

Bildungsexpansion und Bildungsbeteiligung. Oder: warum immer mehr Schulpflichtige das Gymnasium besuchen

Die vorliegende Untersuchung ist ein Beitrag, die Frage zu klären, warum in der westdeutschen Nachkriegszeit immer mehr Schulpflichtige nach Abschluss der Grundschule das Gymnasium besuchen. Ausgehend von einem entscheidungstheoretischen Modell der subjektiven Werterwartung werden Mechanismen der elterlichen Bildungsentscheidung aufgezeigt. Dabei wird davon ausgegangen, dass sowohl zunehmende Bildungsmotivationen als auch Veränderungen in der subjektiven Bewertung von Kosten und Nutzen für eine höhere Bildung wichtige Voraussetzungen für die zunehmende Bildungsbeteiligung, aber auch Folgen der Bildungsexpansion waren. Die empirischen Analysen für drei Zeitpunkte in den 60er, 70er und 80er Jahren bestätigen diese Annahmen weitgehend. Ebenso wurde empirisch belegt, welch wichtige Rolle neben den Bildungsintentionen von Eltern und dem vorhergehenden Bildungsverlauf ihrer Kinder auch strukturelle Momente der Bildungsexpansion und ihre Eigendynamik beim tatsächlichen Bildungsübergang spielen. Schließlich gibt es Hinweise dafür, dass die Persistenz klassenspezifischer Bildungsungleichheiten auf einer konstanten Balance von Nutzen und Kosten zwischen den sozialen Klassen basiert.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

Background Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. Methods A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. Discussion The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).

Exploring the use of pharmaceutical patient assistance programs as an option to improve access to and affordability of prescription drugs

Background. Pharmaceutical-sponsored patient assistance programs (PAPs) are charity programs that provide free or reduced-priced medications to eligible patients. PAPs have the potential to improve prescription drug accessibility for patients but currently there is limited information about their use and effectiveness. ^ Objectives and methods. This dissertation described the use of PAPs in the U.S. through the conduct of two studies: (1) a systematic review of primary studies of PAPs from commercially-published and “grey” literature sources; and (2) a retrospective, cross-sectional study of cancer patients' use of PAPs at a tertiary care cancer outpatient center. ^ Results. (1) The systematic review identified 33 studies: 15 evaluated the impact of PAP enrollment assistance programs on patient healthcare outcomes; 7 assessed institutional costs of providing enrollment assistance; 7 surveyed stakeholders; 4 examined other aspects. Standardized mean differences calculated for disease indicator outcomes (most of which were single group, pre-posttest designs) showed significant decreases in glycemic and lipid control, and inconsistent results for blood pressure. Grey literature abstracts reported insufficient statistics for calculations. Study heterogeneity made weighted summary estimates inappropriate. Economic analyses indicated positive financial benefits to institutions providing enrollment assistance (cost) compared to the wholesale value of the medications provided (benefit); analyses did not value health outcomes. Mean quality of reporting scores were higher for observational studies in commercially-published articles versus full text, grey literature reports. (2) The cross-sectional study found that PAP outpatients were significantly more likely to be uninsured, indigent, and < 65 years old than non-PAP patients. Nearly all non-PAP and PAP prescriptions were for non-cancer conditions, either for co-morbidities (e.g., hypertension) or the management of treatment side effects (e.g., pain). Oral chemotherapies from PAPs were significantly more likely to be for breast versus other cancers, and be a newer, targeted versus traditional chemotherapy.^ Conclusions. In outpatient settings, PAP enrollment assistance plus additional medication services (e.g., counseling, reminders, and free samples) is associated with improved disease indicators for patients. Healthcare institutions, including cancer centers, can offset financial losses from uncompensated drug costs and recoup costs invested in enrollment assistance programs by procuring free PAP medications. Cancer patients who are indigent and uninsured may be able to access more outpatient medications for their supportive care needs through PAPs, than for cancer treatment options like oral chemotherapies. Because of the selective availability of drugs through PAPs, there may be more options for newer, oral, targeted chemotherapies for the treatment breast cancer versus other for other cancers.^

User benefit assessment by a dynamic LUTI model for Madrid

Assessing users’ benefit in a transport policy implementation has been studied by many researchers using theoretical or empirical measures. However, few of them measure users’ benefit in a different way from the consumer surplus. Therefore, this paper aims to assess a new measure of user benefits by weighting consumer surplus in order to include equity assessment for different transport policies simulated in a dynamic middle-term LUTI model adapted to the case study of Madrid. Three different transport policies, including road pricing, parking charge and public transport improvement have been simulated through the Metropolitan Activity Relocation Simulator, MARS, the LUTI calibrated model for Madrid). A social welfare function (WF) is defined using a cost benefit analysis function that includes mainly costs and benefits of users and operators of the transport system. Particularly, the part of welfare function concerning the users, (i.e. consumer surplus), is modified by a compensating weight (CW) which represents the inverse of household income level. Based on the modified social welfare function, the effects on the measure of users benefits are estimated and compared with the old WF ́s results as well. The result of the analysis shows that road pricing leads a negative effect on the users benefits specially on the low income users. Actually, the road pricing and parking charge implementation results like a regressive policy especially at long term. Public transport improvement scenario brings more positive effects on low income user benefits. The integrated (road pricing and increasing public services) policy scenario is the one which receive the most user benefits. The results of this research could be a key issue to understanding the relationship between transport systems policies and user benefits distribution in a metropolitan context.

The place of DPP-4 inhibitors in the treatment algorithm of diabetes type 2 : a systematic review of cost-effectiveness studies

Tese de mestrado, Epidemiologia, Universidade de Lisboa, Faculdade de Medicina, 2015

Assessing cost-effectiveness in mental health: vocational rehabilitation for schizophrenia and related conditions

Objective: Existing evidence suggests that vocational rehabilitation services, in particular individual placement and support (IPS), are effective in assisting people with schizophrenia and related conditions gain open employment. Despite this, such services are not available to all unemployed people with schizophrenia who wish to work. Existing evidence suggests that while IPS confers no clinical advantages over routine care, it does improve the proportion of people returning to employment. The objective of the current study is to investigate the net benefit of introducing IPS services into current mental health services in Australia. Method: The net benefit of IPS is assessed from a health sector perspective using cost-benefit analysis. A two-stage approach is taken to the assessment of benefit. The first stage involves a quantitative analysis of the net benefit, defined as the benefits of IPS (comprising transfer payments averted, income tax accrued and individual income earned) minus the costs. The second stage involves application of 'second-filter' criteria (including equity, strength of evidence, feasibility and acceptability to stakeholders) to results. The robustness of results is tested using the multivariate probabilistic sensitivity analysis. Results: The costs of IPS are $A10.3M (95% uncertainty interval $A7.4M-$A13.6M), the benefits are $A4.7M ($A3.1M-$A6.5M), resulting in a negative net benefit of $A5.6M ($A8.4M-$A3.4M). Conclusions: The current analysis suggests that IPS costs are greater than the monetary benefits. However, the evidence-base of the current analysis is weak. Structural conditions surrounding welfare payments in Australia create disincentives to full-time employment for people with disabilities.

Cost-effectiveness analysis of a kidney and cardiovascular disease treatment program in an Australian aboriginal population

The objective of the study was to assess, from a health service perspective, whether a systematic program to modify kidney and cardiovascular disease reduced the costs of treating end-stage kidney failure. The participants in the study were 1,800 aboriginal adults with hypertension, diabetes with microalbuminuria or overt albuminuria, and overt albuminuria, living on two islands in the Northern Territory of Australia during 1995 to 2000. Perindopril was the primary treatment agent, and other medications were also used to control blood pressure. Control of glucose and lipid levels were attempted, and health education was offered. Evaluation of program resource use and costs for follow-up periods was done at 3 and 4.7 years. On an intention-to-treat basis, the number of dialysis starts and dialysis-years avoided were estimated by comparing the fate of the treatment group with that of historical control subjects, matched for disease severity, who were followed in the before the treatment program began. For the first three years, an estimated 11.6 person-years of dialysis were avoided, and over 4.7 years, 27.7 person-years of dialysis were avoided. The net cost of the program was $1,210 more per person per year than status quo care, and dialyses avoided gave net savings of $1.0 million at 3 years and $3.4 million at 4.6 years. The treatment program provided significant health benefit and impressive cost savings in dialysis avoided. (C) 2005 by the National Kidney Foundation, Inc.

Mennyit ér a zajterhelés csökkenése? Zajvédelmi intézkedések értékelése a haszonértékelések átvitelével (The value of silence. An application of benefit-transfer methodology for evaluating noise-control actions)

Mind ez ideig a gyakorlatban kevéssé aknázták ki azt a lehetőséget, hogy a természeti tőke pénzbeli értékelése számszerű, egzakt információt nyújthat a döntéshozóknak. A szerzők a zajvédelmi intézkedések példáján keresztül tekintik át a természeti tőkejavak közgazdasági értékelésében rejlő lehetőségeket. Ismertetik a költség-haszon elemzés környezeti javakkal bővített formájának előnyeit, majd az általában elhanyagolt, a nem piaci javak által nyújtott haszon közgazdasági értékelésére alkalmas eljárásokat, külön kitérve a zajterhelés területére. Nagy hangsúlyt helyeznek a haszonfelmérések átvitelének széles körben alkalmazható módszereire. Bemutatják az általuk gyakorlatban végzett kutatás során szerzett tapasztalatokat, különös tekintettel arra, hogy a haszonértékelések átvitele hogyan járulhat hozzá a természeti tőkejavakkal kapcsolatos döntések során a társadalmi haszon maximalizálásához. _____ The paper offers an overview of the economic valuation of transportation-induced noise and cost-benefit analysis of noise-control measures and actions. Although economic valuation can provide hard, monetized data for decision-makers, it is relatively underused in practice. The study focuses on benefit-transfer methodology, where values obtained in previous cases are used as the basis for current evaluation. A specific application of benefit transfer is presented by a recent pilot project in Hungary, whereby a tool was developed for LGOs, enabling them to make preliminary assessments of the benefits of potential noise-control measures and rank possible options. This can help to optimize the benefits to society using limited resources.

Cost-effectiveness of natriuretic peptide-based screening and collaborative care: a report from the STOP-HF (St Vincent's Screening TO Prevent Heart Failure) study

AIMS: Prevention of cardiovascular disease and heart failure (HF) in a cost-effective manner is a public health goal. This work aims to assess the cost-effectiveness of the St Vincent's Screening TO Prevent Heart Failure (STOP-HF) intervention.

METHODS AND RESULTS: This is a substudy of 1054 participants with cardiovascular risk factors [median age 65.8 years, interquartile range (IQR) 57.8:72.4, with 4.3 years, IQR 3.4:5.2, follow-up]. Annual natriuretic peptide-based screening was performed, with collaborative cardiovascular care between specialist physicians and general practitioners provided to patients with BNP levels >50 pg/mL. Analysis of cost per case prevented and cost-effectiveness per quality-adjusted life year (QALY) gained was performed. The primary clinical endpoint of LV dysfunction (LVD) with or without HF was reduced in intervention patients [odds ratio (OR) 0.60; 95% confidence interval (CI) 0.38-0.94; P = 0.026]. There were 157 deaths and/or emergency hospitalizations for major adverse cardiac events (MACE) in the control group vs. 102 in the intervention group (OR 0.68; 95% CI 0.49-0.93; P = 0.01). The cost per case of LVD/HF prevented was €9683 (sensitivity range -€843 to €20 210), whereas the cost per MACE prevented was €3471 (sensitivity range -€302 to €7245). Cardiovascular hospitalization savings offset increased outpatient and primary care costs. The cost per QALY gain was €1104 and the intervention has an 88% probability of being cost-effective at a willingness to pay threshold of €30 000.

CONCLUSION: Among patients with cardiovascular risk factors, natriuretic peptide-based screening and collaborative care reduced LVD, HF, and MACE, and has a high probability of being cost-effective.

TRIAL REGISTRATION: NCT00921960.

Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial

Background
Increasing physical activity in the workplace can provide employee physical and mental health benefits, and employer economic benefits through reduced absenteeism and increased productivity. The workplace is an opportune setting to encourage habitual activity. However, there is limited evidence on effective behaviour change interventions that lead to maintained physical activity. This study aims to address this gap and help build the necessary evidence base for effective, and cost-effective, workplace interventions

Methods/design
This cluster randomised control trial will recruit 776 office-based employees from public sector organisations in Belfast and Lisburn city centres, Northern Ireland. Participants will be randomly allocated by cluster to either the Intervention Group or Control Group (waiting list control). The 6-month intervention consists of rewards (retail vouchers, based on similar principles to high street loyalty cards), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of participating workplaces will promote and monitor minutes of physical activity undertaken by participants. Both groups will complete all outcome measures. The primary outcome is steps per day recorded using a pedometer (Yamax Digiwalker CW-701) for 7 consecutive days at baseline, 6, 12 and 18 months. Secondary outcomes include health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Process measures will assess intervention “dose”, website usage, and intervention fidelity. An economic evaluation will be conducted from the National Health Service, employer and retailer perspective using both a cost-utility and cost-effectiveness framework. The inclusion of a discrete choice experiment will further generate values for a cost-benefit analysis. Participant focus groups will explore who the intervention worked for and why, and interviews with retailers will elucidate their views on the sustainability of a public health focused loyalty card scheme.

Discussion
The study is designed to maximise the potential for roll-out in similar settings, by engaging the public sector and business community in designing and delivering the intervention. We have developed a sustainable business model using a ‘points’ based loyalty platform, whereby local businesses ‘sponsor’ the incentive (retail vouchers) in return for increased footfall to their business.

Carcinoma of unknown primary (CUP); some considerations about pathogenesis and diagnostic strategy, particularly focusing on CUPS pertaining to the Urology

he term "carcinoma of unknown primary" (CUP) defines a malignant condition in which a metastatic cancer is documented in absence of a detectable primary site. It occurs in about 2÷6 % of cancer patients, according to various literature reports. The primary tumor site results indefinable because of several either single or associated factors, even remaining occult at autopsy in 15÷25% of CUP patients. The metastatic spread pattern of CUP is quite unlike that expected for analogous known primary malignancy. For instance, the unknown prostate cancer often metastasizes to the lungs and liver while the its known analogous usually spreads to the bone. Whether certain genetic abnormalities might play a role in determining a CUP condition, it remains undefined. Most CUP are adenocarcinoma, squamous cell carcinoma, either undifferentiated or differentiated carcinoma, whereas less frequently may be sarcoma, melanoma or neuroendocrine tumor. As CUP diagnostic management is concerned, two opposite approach modalities may be adopted, one, named "shotgun modality", consisting in a multiplicity of examinations aimed at achieving the identification of the primary tumor and the other, a nihilistic modality, by adopting tout court a palliative therapy of the metastatic disease. A reasonable intermediate diagnostic strategy consists in undertaking some procedures with a specific target and low cost/benefit ratio. Selected imaging studies, serum tumor markers, immunohistochemical analyses and genetic- molecular examinations on biopsy material allow sometimes to reach the detection of primary malignancies that might be responsive to a potential treatments. Nevertheless, in spite of recent sophisticated -laboratory and imaging progress, CUP remains a strong challenge in clinical oncology.

Avaliação de técnicas de classificação digital de imagens landsat em diferentes padrões de cobertura da terra em Rondônia

Remotely sensed imagery has been widely used for land use/cover classification thanks to the periodic data acquisition and the widespread use of digital image processing systems offering a wide range of classification algorithms. The aim of this work was to evaluate some of the most commonly used supervised and unsupervised classification algorithms under different landscape patterns found in Rondônia, including (1) areas of mid-size farms, (2) fish-bone settlements and (3) a gradient of forest and Cerrado (Brazilian savannah). Comparison with a reference map based on the kappa statistics resulted in good to superior indicators (best results - K-means: k=0.68; k=0.77; k=0.64 and MaxVer: k=0.71; k=0.89; k=0.70 respectively for three areas mentioned). Results show that choosing a specific algorithm requires to take into account both its capacity to discriminate among various spectral signatures under different landscape patterns as well as a cost/benefit analysis considering the different steps performed by the operator performing a land cover/use map. it is suggested that a more systematic assessment of several options of implementation of a specific project is needed prior to beginning a land use/cover mapping job.