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Value in Health : the Journal of the... Sep 2021The value of real-world evidence (RWE) in medicines regulation and health technology assessment has been increasingly emphasized. Nevertheless, although RWE is...
The value of real-world evidence (RWE) in medicines regulation and health technology assessment has been increasingly emphasized. Nevertheless, although RWE is increasingly used, there has been limited systematic evidence of its value. A recent study that examined the role and impact of RWE in regulatory assessments conducted through the European Medicines Agency provided such evidence. Results of the study demonstrated RWE was important to decision making, particularly for certain questions such as the quantification of adverse events, the evaluation of risk minimization measures, and the assessment of product usage. The study suggested, however, that in many of the assessments further RWE would have been valuable and concluded that RWE has, as yet, played a limited role in hypothesis generation and in the assessment of medication effectiveness. This study had been possible only because of the transparency of the European Medicines Agency decision making. Ensuring transparency of RWE evidence collection, study design and conduct, and of decision making based on this evidence will facilitate further development of the uses and value of RWE. Keywords: benefit-risk assessment; medicines regulation; real-world evidence; regulatory decision making.
Topics: Decision Making; Evidence-Based Medicine; Government Regulation; Humans; Research Design; Risk Assessment; Technology Assessment, Biomedical; United States
PubMed: 34452702
DOI: 10.1016/j.jval.2021.03.020 -
Israel Journal of Health Policy Research Jun 2019Learning about the abandonment of moral principles of healthcare professionals and scientists, their societies and academic institutions, to a murderous ideology yields...
Learning about the abandonment of moral principles of healthcare professionals and scientists, their societies and academic institutions, to a murderous ideology yields fundamental concerns and global implications for present and future healthcare professionals' education and practice. Medicine's worst-case scenario raises deeply disturbing yet essential questions in the here and now: Could the Holocaust, one of the greatest evils ever perpetrated on humankind, have occurred without the complicity of physicians, their societies, and the scientific profession community? How did healers become killers? Can it happen again?We reflect here on those queries through the lens of the Second International Scholars Workshop on Medicine during the Holocaust and Beyond held in the Galilee, Israel on May 7-11, 2017 and derive contemporary global lessons for the healthcare professions. Following a brief historical background, implications of the history of medicine in the Holocaust are drawn including 1) awareness that the combination of hierarchy, obedience, and power constitutes a risk factor for abuse of power in medicine and 2) learning and teaching about medicine in the Holocaust and beyond is a powerful platform for supporting professional identity formation. As such, this history ideally can help "equip" learners with a moral compass for navigating the future of medical practice and inherent ethical challenges such as prejudice, assisted reproduction, resource allocation, obtaining valid informed consent, end of life care, and challenges of genomics and technology expansion. Curriculum modules are available and studies on impact on students' attitudes and behavior are emerging.The conference culminated with the launch of the Galilee Declaration, composed and signed by an international, inter-professional community of historians, healthcare professions educators, and ethicists. The Declaration included herein ( http://english.wgalil.ac.il/category/Declaration ) calls for curricula on history of healthcare professions in the Holocaust and its implications to be included in all healthcare professions education.
Topics: Career Choice; Education, Medical; Ethics, Medical; History, 20th Century; History, 21st Century; Holocaust; Humans; Israel; Medicine; Physicians
PubMed: 31248455
DOI: 10.1186/s13584-019-0327-3 -
Developmental Medicine and Child... Oct 2014
Topics: Humans; Medicine; Persuasive Communication
PubMed: 25208967
DOI: 10.1111/dmcn.12577 -
Journal of Translational Medicine Aug 2014Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular...
Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular biology and clinical care. The field of translational medicine is charged with mediating this revolution. Sequencing innovations are far outpacing guidelines intended to ease their practice-based applications, including in primary care. As a result, genomic medicine's full integration in primary care settings especially, has been slow to materialize. Researchers and clinicians alike face substantial challenges in navigating contentious ethical issues raised in translation and implementation, namely preserving the spirit of whole-person approaches to care; maintaining respect for persons and communities; and translating genetic risk into clinical actionability. This commentary therefore explores practical barriers to, and ethical implications of, incorporating genomic technologies in the primary care sector. These ethical challenges are both philosophical and infrastructural. From a primary care perspective, the commentary further reviews the ethical, legal and social implications of the Center for Disease Control's proposed model for assessing the validity and utility of genomic testing and family health history applications. Lastly, the authors provide recommendations for future translational initiatives that aim to maximize the capacities of genomic medicine, without compromising primary care philosophies and foundations of practice.
Topics: Ethics, Medical; Genetics, Medical; Genome, Human; Genomics; Human Genome Project; Humans; Inventions; Primary Health Care; Translational Research, Biomedical
PubMed: 25164605
DOI: 10.1186/s12967-014-0238-6 -
BMC Medical Ethics Aug 2021Precision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number... (Review)
Review
BACKGROUND
Precision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review.
METHODS
We used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided 665 different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine.
RESULTS
Many patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health.
CONCLUSIONS
National legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine's benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients' decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment.
Topics: Artificial Intelligence; Humans; Informed Consent; Physician-Patient Relations; Precision Medicine; Quality of Life
PubMed: 34465328
DOI: 10.1186/s12910-021-00682-8 -
Journal of the American Medical... Jul 2016Precision medicine approaches disease treatment and prevention by taking patients' individual variability in genes, environment, and lifestyle into account. Although the...
Precision medicine approaches disease treatment and prevention by taking patients' individual variability in genes, environment, and lifestyle into account. Although the ideas underlying precision medicine are not new, opportunities for its more widespread use in practice have been enhanced by the development of large-scale databases, new methods for categorizing and representing patients, and computational tools for analyzing large datasets. New research methods may create uncertainty for both healthcare professionals and patients. In such situations, frameworks that address ethical, legal, and social challenges can be instrumental for facilitating trust between patients and providers, but must protect patients while not stifling progress or overburdening healthcare professionals. In this perspective, we outline several ethical, legal, and social issues related to the Precision Medicine Initiative's proposed changes to current institutions, values, and frameworks. This piece is not an exhaustive overview, but is intended to highlight areas meriting further study and action, so that precision medicine's goal of facilitating systematic learning and research at the point of care does not overshadow healthcare's goal of providing care to patients.
Topics: Confidentiality; Health Personnel; Humans; Informed Consent; Patient Participation; Precision Medicine
PubMed: 26977101
DOI: 10.1093/jamia/ocv215 -
Hellenic Journal of Nuclear Medicine 2020Current literature records a glaring discrepancy between the rapid developments and progress of medicine and the simultaneous deterioration of the quality and safety of... (Review)
Review
Current literature records a glaring discrepancy between the rapid developments and progress of medicine and the simultaneous deterioration of the quality and safety of the provided health care services. Bibliographic data as far as perceptions of quality and safety in nuclear medicine departments are concerned, are limited and frequently ambiguous. Most nuclear medicine departments provide the same types of services, but not the same quality of service, while patients' perceptions are not always matched by the perceptions of health care providers. The multidimensional nature of quality and safety, deriving from the different criteria and standards by which different groups of the population attempt to interpret and evaluate them, justifies these discrepancies, over most of quality's and safety's dimensions studied. Nuclear medicine's unique characteristic of using radiopharmaceuticals, exposing to ionizing radiation affects dramatically these perceptions, irrespective of whether quality and safety assurance measures already cover radiation protection, instrumentation maintenance, radiopharmaceutical handling, and the management of all the other aspects of patient care. On the other end of the spectrum, patient-centred practice, communication and proper information play as a well decisive role in ensuring patients' satisfaction.
Topics: Humans; Nuclear Medicine; Quality Control; Safety
PubMed: 32361717
DOI: 10.1967/s002449912016 -
BMC Medical Education Apr 2023Healthcare systems often face shortages of certain medical specialists due to lack of interest among medical students. We questioned a common "one solution fits all"...
BACKGROUND
Healthcare systems often face shortages of certain medical specialists due to lack of interest among medical students. We questioned a common "one solution fits all" approach to this problem which involves monetary incentives to lure students to these specialties. Instead, we used the marketing principle the "consumer knows best" to explore ways of elucidating the reasons and proposing solutions for such shortages.
METHODS
A convenience sample of Israeli 6th-year medical students and interns completed questionnaires to determine why they thought three specialties (geriatrics, anesthesiology, emergency medicine) were unpopular and their ideas on increasing their appeal.
RESULTS
119 6th-year students and 84 interns completed questionnaires. Geriatrics was reported having a problematic patient population; not being interesting and challenging; and not considered prestigious by colleagues and the populace. This contrasts with emergency medicine which, although considered prestigious, has difficult working conditions both during and after residency accompanied by much pressure at work. Although, improvements in lifestyle and remuneration were thought by students and interns as possibly making these specialties more attractive, reducing the pressure at work and decreasing on-call obligations were designated by the students/interns as ways to increase emergency medicine's and anesthesiology's appeal. Half the students replied that anesthesiology would be more appealing if work was in shifts (< 16 h), while 60% replied so for emergency medicine and only 18% for geriatrics. 90% of students reported that control over lifestyle would make emergency medicine more attractive while 55% and 48% replied positively for anesthesiology and geriatrics, respectively.
CONCLUSIONS
Using the concept "consumer knows best" provided additional insight into the specialty selection process. Students/interns have specialty-specific opinions as to why some specialties are unpopular. Their ideas about attracting more students to these specialties were also specialty-dependent, i.e. "one solution does not fit all". These observations render problematic a single solution aimed at ameliorating the workforce shortages of multiple specialties. Instead, these results advocate a differential approach wherein the lack of appeal of each unpopular specialty is analyzed individually and the students'/interns' (the "consumers") ideas sought resulting in solutions tailored to address each specialty's lack of attractiveness.
TRIAL REGISTRATION
None.
Topics: Humans; Career Choice; Anesthesiology; Emergency Medicine; Surveys and Questionnaires; Students, Medical; Internship and Residency
PubMed: 37081461
DOI: 10.1186/s12909-023-04241-0 -
Family Medicine and Community Health Apr 2024is a 12-part series of thematically linked mini-essays with accompanying illustrations that explore the many dimensions of family medicine, as interpreted by individual...
is a 12-part series of thematically linked mini-essays with accompanying illustrations that explore the many dimensions of family medicine, as interpreted by individual family physicians and medical educators in the USA and elsewhere around the world. In 'XII: Family medicine and the future of the healthcare system', authors address the following themes: 'Leadership in family medicine', 'Becoming an academic family physician', 'our call to act', 'The paradox of primary care and three simple rules', 'The quadruple aim-melding the patient and the health system', 'Fit-for-purpose medical workforce', 'Universal healthcare-coverage for all', 'The futures of family medicine' and 'The 100 essay.' May readers of these essays feel empowered to be part of family medicine's exciting future.
Topics: Humans; Family Practice; Physicians, Family; Emotions; Health Facilities; Universal Health Care
PubMed: 38609091
DOI: 10.1136/fmch-2024-002829 -
Biochimie May 2022Clinicians are increasingly using regenerative medicines to repair, replace, regenerate or rejuvenate lost, damaged or diseased genes, cells, tissues or organs. In South... (Review)
Review
Clinicians are increasingly using regenerative medicines to repair, replace, regenerate or rejuvenate lost, damaged or diseased genes, cells, tissues or organs. In South Africa, access to these novel gene therapies and cell and tissue-based products is limited. The human leukocyte antigen (HLA) diversity and a paucity of suitable HLA-identical unrelated donors, results in limited access to haematopoietic stem and progenitor cell transplantation (HSPCT). Cell-based products could increase this access. Genetic diversity can also manifest in local or region-specific rare congenital disorders, and in vivo gene therapies hold the promise of developing treatments and cures for these debilitating disorders. South Africa has a disproportionate mortality rate due to non-natural causes, with many surviving with permanent injuries and disabilities. Tissue-engineered cell-based products have the potential to restore many of those affected and improve quality of life and productivity. These factors create an urgency for South Africa to develop regenerative medicines to address the country's unique needs and to provide access to these new and innovative treatment modalities. Achieving this objective requires a well-coordinated effort by multiple stakeholders and role players. A critical component of a regenerative medicine ecosystem is establishing an enabling regulatory framework for these new classes of medicines. Here we provide a brief profile of South Africa, including its genetic diversity, economy, the impact of the burden of disease, health policy and the healthcare system. We address the regulation of medicines, how the existing framework can accommodate regenerative medicines, and the steps needed to establish a future regulatory framework.
Topics: Ecosystem; Genetic Therapy; Humans; Quality of Life; Regenerative Medicine; South Africa
PubMed: 35248613
DOI: 10.1016/j.biochi.2022.02.010