A mixed-methods approach to elucidate SARS-CoV-2 transmission routes and clustering in outbreaks in native workers and labour migrants in the fruit and vegetable packaging industry in South Holland, the Netherlands, May to July 2020.

Objectives: To obtain insight into SARS-CoV-2 clustering and transmission routes during outbreaks in the predominantly migrant workforce of the fruit and vegetable packaging industry of South Holland, the Netherlands, May to July 2020.

Design: This mixed-methods study applied direct observation and interviews, epidemiologic investigation, source and contact data analysis and whole-genome sequencing.

Results: We detected 46 SARS-CoV-2 cases and 4 outbreaks with a proportional representation of labour migrant and native workers in 6 unrelated facilities.

Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk.

The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities.

Reconsidering the ethics of sham interventions in an era of emerging technologies.

Background: Our aim was to ethically evaluate the arguments in favor and against sham interventions, as presented in literature. Two developments underscore the need to reconsider the ethics of sham interventions. First, the number of clinical trials investigating interventions in the field of regenerative medicine are increasing, in which the choice for a placebo requires an invasive intervention.

Societal impacts of regenerative medicine: reflections on the views of orthopedic professionals.

As the amount of clinical studies in orthopedic regenerative medicine (RM) is increasing, it is time to take into account its impact on society. A total of 36 biomedical professionals working at the front row of orthopedic RM were interviewed to explore their attitudes, opinions and expectations regarding the societal impacts of RM. Professionals mainly recognized the societal impacts of counteraction of aging, prevention of disease and social justice.

Ethical implications of regenerative medicine in orthopedics: an empirical study with surgeons and scientists in the field.

Background Context: Regenerative medicine (RM) interventions, such as (stem) cell transplantation, scaffolds, gene transfer, and tissue engineering, are likely to change the field of orthopedics considerably. These strategies will significantly differ from treatments in current orthopedic practice, as they treat the underlying cause of disease and intervene at a biological level, preferably in an earlier stage. Whereas most of the RM interventions for orthopedics are still in the preclinical phase of research, the number of clinical studies is expected to increase rapidly in the future.

Stem cell trials for cardiovascular medicine: ethical rationale.

Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration.

Regenerative medicine interventions for orthopedic disorders: ethical issues in the translation into patients.

Regenerative medicine (RM) technologies, such as cell therapy, gene transfer and tissue engineering, are expected to move the field of orthopedics into a new era. Now that more and more attempts are underway to translate preclinical research into clinical studies, it is time to proactively discuss the ethical issues associated with first-in-human applications of RM interventions for musculoskeletal disorders. The design and launch of early clinical trials will be ethically challenging due to the specific features of RM in general, and the application for musculoskeletal disorders specifically.

Anosmia after coiling of ruptured aneurysms: prevalence, prognosis, and risk factors.

Background And Purpose: Anosmia occurs frequently in patients with subarachnoid hemorrhage (SAH) from a ruptured aneurysm treated with clipping. We analyzed prevalence, prognosis, and potential risk factors for anosmia after coiling for SAH.

Methods: We interviewed all patients who resumed independent living after SAH treated with coiling between 1997 and 2007.