Assessing the ethics of prison policies to ensure human rights compliance. Suicides and self-inflicted critical events in Italian prisons

Considering self-inflicted critical events (suicides, attempted suicides, self-harm acts, hunger strikes) in Italian prisons as indicators of the respect of inmates’ human rights, this study examines their relationship with the characteristics of the Italian prison system between 2016 and 2021, using a unique prison-level dataset covering the 188 national prisons. Both individual panel regressions and seemingly unrelated regressions show that reducing prison overcrowding reduces critical events. The same result is achieved by increasing mandatory treatments (restraint acts) performed discretionally by prison staff. Because the former policy is politically sensitive and difficult/costly to implement, policymakers may prefer to rely on the latter as a “death-avoidance strategy”, despite the greater likelihood of violating inmates’ human rights. These findings may help explain the increasing use of acts of restraint in Italian prisons in recent times

SIR-Spheres® Y-90 resin microspheres in chemotherapy refractory or intolerant patients with metastatic colorectal cancer:

Selective internal radiation therapy is a form of intra-arterial brachytherapy used to treat primary liver cancer and liver metastases. This article aims to provide an overview of the clinical, economic, organizational legal, social and ethical impact of selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres in the treatment of patients with unresectable, liver-dominant metastatic colorectal cancer who are refractory to or intolerant of chemotherapy. A systematic literature review was performed by querying PubMed, Scopus, EBSCO, CRD and GIN. Two reviewers blindly screened the records retrieved against predefined inclusion/exclusion criteria. The selected studies where summarized following a simplified version of the EuNetHTA Core Model® 2.1. The studies included evaluated selective internal radiation therapy in first-line or further-line treatment and showed a good safety and tolerability profile and significant improvement in efficacy expressed as time to liver progression, progression-free survival and overall survival. Selective internal radiation therapy should be provided in specialized centres and administered by a multidisciplinary team. A hub-and-spoke network could be a viable option to guarantee access to this technology across jurisdictions. The lack of a specific diagnosis-related group tariff accounting for the cost of the device could be seen as the major obstacle to a fair diffusion of this technology. The economic evaluations currently available show the cost-effectiveness of this technology in the population under study. Selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres appears to be a clinically effective and cost-effective option in the treatment of metastatic colorectal cancer patients who are chemotherapy refractory or chemotherapy intolerant

Converbs, Medial Verbs, Clause Chaining and Related Issues

This volume grew out of a workshop on "Converbs, medial verbs, clause chaining and related issues" held at Leiden University on 8th December 2006, which was cosponsored by the Swiss National Science Fotmdation (SNF) project "Functional typology of Ethiopian languages" (no. 100012-\09306). That occasion brought together specialists working on a range of languages spoken in a circle that spans from New Caledonia via India to Ethiopia and Mozambique. All while struggling to find a common language to talk about phenomena that are so pervasive in our respective languages of investigation, our discussions greatly benefited from the pooling of experiences in fields between which scientific exchange is often obstructed by the boundaries of various traditions. Far from adhering all to one theory or perspective, we hope that bringing together the following articles in one volume will provide new data and insights for tile already lively discussion around converbs, medial verbs and related issues. We wish to thank the editorial board of the Frankfurter Afrikanistische Blatter for accepting this volume in their journal and for their willingness to publish articles that go beyond African languages. In the same vein, we wish to thank all contributors to this volume, and especially our non-Africanist colleagues that have crossed one or more continental and disciplinary divides by publishing in this journal. Special mention and thanks are due to Sascha Völlmin, who did the layout of the whole volume. Finally, we hereby gratefully acknowledge the financial and logistical support of the workshop by the Institute of African Languages and Cultures, Leiden, and the Swiss National Science Foundation

Assessing social and economic impact of subcutaneous mAbs in oncology

Background: Rituximab and trastuzumab were the first monoclonal antibodies (mAbs) approved for the treatment of cancer patients. Both antibodies are administered intravenously (EV), but subcutaneous (SC) formulations have recently been developed. SC formulations proved to be as safe and effective as EV and to offer substantial benefits to the patient. Objective: The aim of this study was to provide a multidimensional assessment of the impact of rituximab and trastuzumab SC compared to the EV formulation, providing a particular focus on expected social and economic benefits for the patient. Methods: The best established HTA methods were applied to gather and organize evidence concerning the clinical, economic, organizational, social and ethical impact of SC formulations of rituximab and trastuzumab. Social aspects were investigated applying regression methods to data collected with a previous research, while the potential savings associated with the use of SC formulations were estimated by a simple economic model applying the societal perspective. Results Patients undergoing subcutaneous formulation are significantly more satisfied with their treatment experience than those treated with intravenous formulation. Subcutaneous formulation reduces patient dosing times, with a positive effect on the care provider's autonomy and productivity. Potential savings associated with the use of rituximab SC were estimated in € 4,050 per patient per year on average. For trastuzumab SC the estimated potential savings amounted to € 3,400 per patient per year, on average. Conclusion Rituximab and trastuzumab are promising treatment options significantly improving patients qol and reducing the treatment burden in terms of societal costs

New opportunities in Haemophilia treatment: Efmoroctocog Alfa for patients with Haemophilia A

Recently new opportunities are emerging for improving the way patients with Haemophilia A are treated. Among these opportunities, efmoroctocog alfa is a first-in-class recombinant factor VIII-Fc fusion protein (rFVIIIFc) produced by recombinant DNA technology with an extended half-life compared with conventional FVIII preparations. The available evidence coming from an Italian HTA report indicates that efmoroctocog alfa provides an effective alternative to conventional FVIII preparations (including standard rFVIIIs) for the management of Haemophilia A. Moreover, by reducing the frequency of injections required, it has the potential to reduce treatment burden, and hence improve adherence to prophylaxis and patient Quality-of-Life.&nbsp

A new decision model for economic evaluation of novel therapies for HCV

In 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is intended to provide a tool for the decision-maker that seeks to address the main issues related to the introduction of HCV new treatments. The model that we have structured follows the classic Bayesian approach, using data from reference literature for staging the action of treatments depending on the level of fibrosis (F0, F1, F2, F3, F4). The model is designed to consider patients with all genotypes and allows to make comparisons between innovative and traditional therapies (dual, triple, IFN free, PI combinations, etc.), for both experienced and naïve patients. In addition, the model is used to simulate mixed cohorts of patients, representing a population with HCV with different levels of fibrosis and different genotypes. To show the potential of the model, we created some simple scenarios assuming different levels of SVR and pricing. The results of our model show that, even assuming an SVR rate of 100%, the administration of new treatments for HCV subjects F1 / 2 has an incremental cost-effectiveness ratio not sustainable. In contrast, for the subjects F3 and F4, low incremental SVR rates and an incremental cost of the innovative therapy of € 40,000 would be cost effective. The added value of this model is its versatility and applicability to diverse assessment needs. In addition, the model offers an opportunity for reflection even to the industry, which in the years to come will have to develop strategies for entering the market and offer sustainable prices for decision-makers and at the same time remunerate the investment in research and development consistently with the expectations of the shareholders

New professional roles and patient satisfaction : evidence from a European survey along three clinical pathways

Project is funded by the European Commission, Grant Agreement no: 305467.Peer reviewedPostprin

CUBES : the Cassegrain U-band Efficient Spectrograph

In the era of Extremely Large Telescopes, the current generation of 8-10m facilities are likely to remain competitive at ground-UV wavelengths for the foreseeable future. The Cassegrain U-Band Efficient Spectrograph (CUBES) has been designed to provide high-efficiency (> 40%) observations in the near UV (305-400 nm requirement, 300-420 nm goal) at a spectral resolving power of R >20, 000 (with a lower-resolution, sky-limited mode of R ~7, 000). With the design focusing on maximizing the instrument throughput (ensuring a Signal to Noise Ratio (SNR) ~20 per high-resolution element at 313 nm for U ~18.5 mag objects in 1h of observations), it will offer new possibilities in many fields of astrophysics, providing access to key lines of stellar spectra: a tremendous diversity of iron-peak and heavy elements, lighter elements (in particular Beryllium) and light-element molecules (CO, CN, OH), as well as Balmer lines and the Balmer jump (particularly important for young stellar objects). The UV range is also critical in extragalactic studies: the circumgalactic medium of distant galaxies, the contribution of different types of sources to the cosmic UV background, the measurement of H2 and primordial Deuterium in a regime of relatively transparent intergalactic medium, and follow-up of explosive transients. The CUBES project completed a Phase A conceptual design in June 2021 and has now entered the detailed design and construction phase. First science operations are planned for 2028

Infected pancreatic necrosis: outcomes and clinical predictors of mortality. A post hoc analysis of the MANCTRA-1 international study

: The identification of high-risk patients in the early stages of infected pancreatic necrosis (IPN) is critical, because it could help the clinicians to adopt more effective management strategies. We conducted a post hoc analysis of the MANCTRA-1 international study to assess the association between clinical risk factors and mortality among adult patients with IPN. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality. We identified 247 consecutive patients with IPN hospitalised between January 2019 and December 2020. History of uncontrolled arterial hypertension (p = 0.032; 95% CI 1.135-15.882; aOR 4.245), qSOFA (p = 0.005; 95% CI 1.359-5.879; aOR 2.828), renal failure (p = 0.022; 95% CI 1.138-5.442; aOR 2.489), and haemodynamic failure (p = 0.018; 95% CI 1.184-5.978; aOR 2.661), were identified as independent predictors of mortality in IPN patients. Cholangitis (p = 0.003; 95% CI 1.598-9.930; aOR 3.983), abdominal compartment syndrome (p = 0.032; 95% CI 1.090-6.967; aOR 2.735), and gastrointestinal/intra-abdominal bleeding (p = 0.009; 95% CI 1.286-5.712; aOR 2.710) were independently associated with the risk of mortality. Upfront open surgical necrosectomy was strongly associated with the risk of mortality (p < 0.001; 95% CI 1.912-7.442; aOR 3.772), whereas endoscopic drainage of pancreatic necrosis (p = 0.018; 95% CI 0.138-0.834; aOR 0.339) and enteral nutrition (p = 0.003; 95% CI 0.143-0.716; aOR 0.320) were found as protective factors. Organ failure, acute cholangitis, and upfront open surgical necrosectomy were the most significant predictors of mortality. Our study confirmed that, even in a subgroup of particularly ill patients such as those with IPN, upfront open surgery should be avoided as much as possible. Study protocol registered in ClinicalTrials.Gov (I.D. Number NCT04747990)