130,739 research outputs found
I nuovi farmaci per l’HCV: una possibile “lezione metodologica”
No full textIl contributo affronta il tema della recente introduzione dei nuovi farmaci per l'HCV argomentando sulla possibilità di utilizzarlo come paradigma per la valutazione dei farmaci innovativ
The clinical ethics consultation (CEC): clarification tool for physicians and patients to avoid complaints?
No full textTitle: The clinical ethics consultation (CEC): clarification tool for physicians and patients to avoid complaints?
Authors: R. Minacori*, D. Sacchini*, N. Comoretto°, and A.G. Spagnolo*
Institutions: * Institute of Bioethics “A. Gemelli” School of Medicine, Università Cattolica del Sacro Cuore (UCSC) – Rome; °Athenaeum Centre for Bioethics - Rome Campus (UCSC)
Learning Objectives
A better understanding of how CEC can reduce the risk of complaints
Background
The CEC aims to help patients, their families, caregivers and healthcare professionals to cope with ethical issues arising in patient care. Less attention has been paid to the impact of CEC on patients/family-doctors relationship and the risk of complaints. A better understanding of how CEC influences this factor might identify opportunities for reduce this risk.
Aim
We examined the role of CEC as tool for improving the quality of patients/family-doctors relationship and to avoid patients complaints.
Methods
We examined 93 CECs conducted at “A. Gemelli” Academic Hospital (January 1994-October 2010), requested from different clinical departments, especially for end-of-life decision making issues with or without mentally incompetent patients. Conflict or fear of conflict by doctors existed. The CEC focused on a wide range of ethical concerns, but also social and medico-legal issues trying to identify key elements that might impact on the patients/family-doctors relationship and could determine disagreement.
Results
The reasons for dissatisfaction of patients/family seems related not only to physicians’ technical skills but also to relationship issues. We observed that relationship difficulties could complicate other issues. The follow-up seems indicate that no complaints has subsequently developed from these cases, some of which are particularly sensitive.
Conclusion
In our experience, the CEC provided a help to analyze from the ethical point of view the most problematic aspects of clinical situations and the possible solutions for decision making. The CEC also facilitated the physician/patient/family interaction, clarifying the objectives of care for patient’s best interest and encouraging decisions sharing
Exploring the ethical issues of digital therapeutics (DTx)
No full textDigital therapeutics (DTx) are innovative evidence-based medical interventions, driven by high-
quality software programs to prevent, manage, or treat diseases of patients. DTx are also defined
as “drugs” where algorithms are the active ingredient instead of a chemical or biological
substance. DTX can be used alone or in combination with other devices or medications.
DTxs are finding application in a variety of areas, including chronic diseases (type II diabetes,
hypertension, obesity, insomnia, Alzheimer’s), and above all addictions (alcohol, smoking, and
drugs). Today there are roughly 35 to 40 products on the market, 8 of which approved by
regulatory agencies. The value of the global DTx market has been estimated at USD 1.8 billion in
2018, and it is expected to reach USD 8.9 billion by 2027.
DTx differ from common wellness apps or medication reminder tools in that they require
“rigorous” clinical evidence. However, their use raises a number of ethical concerns. Aim of the
present work is to provide an overview of the main ethical issues pertaining the assessment of this
emerging technology. The final purpose is to support and facilitate an open and transparent
ethical debate with regard to DTx
Introduction to Ethics in Health Technology Assessment. HTAi 2021 Annual Meeting
No full textThis workshop will deepen understanding the role of Hospital Based HTA on the decision making; participants will
learn the steps for developing an assessment in hospital-based context and tools to perform a rapid assessment; it
will be presented the implementation process of its recommendations. For each section there is an analysis of the
impact of the pandemic.
The coronavirus pandemic has changed the global scenario regarding healthcare and the use of tools such as HB-HTA.
Operational processes have become much faster and there has been a greater need for information on technologies
for diagnosing and treating COVID. Which of these had a rationale, some potential evidence, which impact on the
organization and which costs. All questions to which the Hospital Based HTA was asked to give answers that required
its reorganization both of a methodological and operational type. The workshop aims to illustrate these changes
resulting from real experiences lived in different parts of the globe.
1. Main role of HB-HTA – functions
2. Has HB-HTA role changed as a consequence of the pandemic?
3. Steps for a HB-HTA, relying on AdHopHtA
4. Rapid Assessment? Criteria
4.a. Assessment of clinical outcomes, evidence level and safety
4.b. Assessment with real world HTA
4.c. Assessment of patient perception
4.d. Assessment of economic consequences
4.e. Assessment of organizational consequences
4.f. Assessment of other potential aspects: Strategical, legal, ethical etc.
4.g. How to ensure the quality of HB HTA?
5. Implementation process of the HB-HTA recommendations into the hospital decision making. Impact of
pandemic
6. Discussion and closing
• To give the participants:
- an understanding of how HB HTA can be organized, produced and implemented at hospitals as the basis for
decisions on investment in new health technologies
- skills to produce high quality HB HTAs on their hospitals on the basis of the evidence from the AdHopHTA project.
• To show potentials of HB-HTA to push for value-based innovations in hospitals
• To discuss examples of HB HTAs including assessments of innovative, digital health technologies produced within
hospitals.
• To share the challenges and strategies to implement and carry out HB-HTA in the pandemic contex
Trasfusioni di sangue
No full textLa voce affronta il tema gli aspetti etici relativi alle trasfusioni di sangu
Spectrophotometric micro-method for ethanol determination in commercial beverages
No full textA sensitive spectrophotometric method for the determination of ethanol with potassium dichromate was developed. Chromium(VI), in 7 mol/L perchloric acid, reacts quantitatively with ethanol to form chromium(III) and acetic acid. The reaction is complete in about 15 min at room temperature and the chromium(VI) consumed may be determined by the decrease of the absorbance at 267 nm. The analytical
working parameters (such as acidity and ionic strength of the solution, temperature and time of the reaction, chromium(VI) concentration, matrix interferences) were optimized. The apparent molar absorptivities of chromium(VI), in the monomer and dimer form, and the equilibrium quotient for the dimerization reaction were determined in 3 mol L-1 perchloric acid solution.
The method was applied to the analysis of micro samples of commercial beverages (beers, wines and spirits) without the previous distillation of ethanol
Introduction to Ethics in Health Technology Assessment
No full textThe course has been specifically developed for international participants and is based on more recent international achievements in the field. It will emphasize adapting approaches in ethics for all types of health technologies and across international settings. Participants who attend this course will strengthen their understanding and facilitate their participation in ethical assessment in HTA, as well their ability to participate in broader discussions. Most importantly it provides a number of approaches for ‘how to’ incorporate ethics into an HTA.
After the preconference workshop participants will be able to:
• explain and acknowledge the role of ethical issues in HTA;
• recognize potential ethical issues in HTA and formulate appropriate research questions,
• know about and use methods for analysing ethical issues;
• know how to find and critically approach literature used when identifying ethical implications of health care technologies;
• describe different ways of synthesizing and communicating the results of an ethics analysis
The Equitable Benefit Approach to guide the assessment of medical and psychosocial factors in liver transplant candidacy
No full textLack of available organs poses a significant challenge in meeting the needs of patients with life-threatening liver disease who could benefit from liver transplantation (LT). Psychosocial vulnerability markers have been linked to post-transplant outcomes, raising questions about their use in patient selection. However, their incorporation into selection criteria raises concerns about health equity and potential discrimination. As a result, there is a pressing need to refine fair allocation systems that consider both clinical and psychosocial factors to ensure equitable access and optimize post-transplant outcomes. The Equitable Benefit Approach (EBA) proposed in this paper by the multidisciplinary group of clinical experts in LT from the Italian Society for the Study of the Liver seeks to address these concerns. It presents four procedural principles, the two allocative principles usually applied in transplantation (urgency and utility) and introduces a new one, the principle of health equity. The EBA aims to prioritize patients with the highest transplant benefit while addressing health inequalities. It emphasizes evidence-based decision-making and standardized assessment tools to reliably evaluate psychosocial risk factors. Implementing the EBA involves a multi-step process, including stakeholder engagement, prospective studies to validate its efficacy, development of institutional policies and algorithms, and ongoing monitoring and revision. By following these steps, health care providers can ensure that LT allocation decisions are transparent and responsive to evolving clinical and social contexts. Ultimately, the EBA should offer a comprehensive framework for fair patient selection in LT, considering both biomedical and psychosocial aspects
Clinical ethics consultation as “shared document”. Emerging ethical and medico-legal issues: Sacchini D., Corsano B., Refolo P., Minacori R., Spagnolo A.G.the experience of IBioMedH-UCSC CEC Service (2005-2016)
No full textBackground
The clinical ethics consultation (CEC) aims to help patients, relatives, caregivers and healthcare professionals to cope with ethical issues arising in patient care. CEC can be drafted in two different ways: 1. CEC provided by clinical ethics consultant requested by clinical wards; 2. CEC as “shared decision-making document” (SDM-D) among different “bedside” stakeholders (patient, relatives, healthcare professionals, health managers) aimed at an agreed advanced clinical planning, namely in dilemmatic/uncertain settings. In fact, SDM is “an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences” (Elwyn et al., 2010)
Aim
Assessing rising ethical/medico-legal issues in clinical cases requested for CEC and addressed through SDM-D.
Methods
We examined retrospectively SDM-Ds provided by IBioMedH-UCSC CEC Service and requested from different clinical Departments of “A. Gemelli” University Hospital Foundation (starting from January 2005 to December 2016), examining clinical indication, patient’s preferences, quality of life; context, in the light of personalist bioethical approach (Sgreccia, 1986)..
Results
53 SDM-Ds out of 173 CECs were setup from 2005 to 2016. Clinical Departments that requested clinical ethics consultation were: Reproductive and maternal-Foetal Diseases (15, 28%); Internal Medicine & Infectious Diseases (12, 23%); Pediatrics and Neonatal care (11, 22%); Neurology (9, 15%); Hospice (3, 6%); Intensive Care Unit (2, 4%); Surgery (1, 2%).
The following main ethical issues were recognized: cardiopulmonary resuscitation; tracheostomy, ectopic pregnancies; inducing childbirth; mechanical ventilation; palliative sedation.
Possible ethical/medico-legal issues were identified: problems of communication and understanding between the parties; patients/family difficulties to identify benefits/burdens of treatments proposed by physicians and the patient’s best interest; incomplete patient’s understanding of physician’s clinical goals; the patient/family request to join the discussion and to share the decisions concerning treatments; the fear of family that the doctors are not doing enough for the patient; for end-of-life patients, the fear that doctors will do unnecessary treatments that produce suffering; the patients/family perception to have distant and seemingly irreconcilable positions with those of the doctors.
The different reasons for dissatisfaction of patients/family seems related not to physicians’ technical skills, but to relationship issues. We observed that relationship difficulties could complicate other issues. In all cases examined, SDM helped to overcome potential conflicts, incomplete understandings or misunderstandings. The consequence of SDM was that no complaints has subsequently developed from these cases, some of which were particularly sensitive.
Conclusion
In our experience, the CEC provided through SDM-D can help: the optimization of the choice of proportionate treatments; to strengthen patients/family-doctors relationship and, at the same time, reduce the risk of complaints/disagreement; to analyse from the ethical point of view, for all the parties, the most problematic aspects of clinical situations and the possible solutions for a really SDM. The CEC-SDM-D can also clarify the goals of care for patient’s best interest
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