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OBJECTIVE: We sought to perform a large-scale systematic review across all sham-controlled studies currently present in the literature to better characterize the ethical considerations of these studies. BACKGROUND: Innovative surgical procedures are often introduced into the clinical setting without the robust clinical trials required for medicinal treatments. Sham surgeries serve as placebos by performing all steps of a surgical intervention aside from those deemed therapeutically necessary. Yet, sham trials are underutilized because of ethical controversy. METHODS: Ovid MEDLINE was queried through April 2022 with combinations of the Medical Subject (MeSH) headings and keywords including, but not limited to, "surgery," "endoscopy," "randomized controlled trial," and "sham procedure." Primary outcomes were surgical indications and characteristics, outcome measurements, and whether the investigational treatment was offered to the sham cohort. RESULTS: One hundred seventy-two articles fit our inclusion criteria, with gastrointestinal pathologies being the most common surgical indication. Participants, personnel, and outcome assessment were all blinded in 8.7% of trials (n=15). Study populations included adult subjects (age ≥18) in 170 studies (98.8%), and two involved children. The most common level of dissection and type of anesthesia were deep (n=66, 38.4%) and general (n=49, 28.5%), respectively. An open surgical approach was utilized in 20.9% of studies (n=36). Primary outcomes were objective in 75 studies (43.6%) and subjective in 97 (56.4%), 62 of which used validated outcome measures (36.0%). Four trials explicitly did not offer the surgery to the sham arm (2.3%), whereas 106 had no mention of whether the intervention was offered (61.6%). CONCLUSIONS: Our systematic review of 172 randomized, sham-controlled trials highlights the ethical considerations that must be considered in these studies, namely the importance of transparent study design and objective outcome reporting, the difficulty of informed consent, and the inherent risks associated with surgical interventions.
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Endoscopía , Proyectos de Investigación , Adulto , Niño , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The goal of this work is to assess the beliefs of US physicians about the national legalization of physician-assisted suicide (PAS). We sent a survey to 1000 randomly chosen physicians from around the US. Our survey indicates that 60% of physicians thought PAS should be legal, and of that 60%, 13% answered "yes" when asked if they would perform the practice if it were legal. Next, 49% of physicians agreed that most patients who seek PAS do so because of pain, and 58% agreed that the current safeguards in place for PAS, in general, are adequate to protect patients. With respect to specific safeguards, 60% disagreed with the statement that physicians who are not psychiatrists are adequately trained to screen for depression in patients seeking PAS, and 60% disagreed with the idea that physicians can predict with certainty whether a patient seeking PAS has 6 months or less to live. Finally, about one-third (30%) of physicians thought that the legalization of PAS would lead to the legalization of euthanasia, and 46% agreed that insurance companies would preferentially cover PAS over possible life-saving treatments if PAS was legalized nationally. Our survey results suggest several conclusions about physicians' beliefs about PAS. The first is that there is a discrepancy between willingness to endorse and willingness to practice PAS. Second, physicians are generally misinformed with regard to why patients seek PAS, and they are uncertain about the adequacy of safeguards. Third, physicians are still wary of the slippery slope with respect to the legalization of PAS nationwide.
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Actitud del Personal de Salud , Médicos/psicología , Suicidio Asistido , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Suicidio Asistido/economía , Suicidio Asistido/ética , Suicidio Asistido/legislación & jurisprudencia , Encuestas y CuestionariosRESUMEN
In fewer than 20 years, five US states have legalized or decriminalized physician-assisted suicide (PAS), and in 2015, about half of all state legislatures considered legalizing it. Since it is medical doctors who typically perform PAS, it is important to understand physicians' views regarding legalization and willingness to perform it. The objective of this study was to determine what physicians believe about the legalization and practice of physician-assisted suicide. A 22 multiple-choice question survey was sent to 1251 current faculty physicians at the Yale School of Medicine. Four hundred and eighty-eight (39%) responded. The majority of physician respondents (73%) agreed that it is sometimes necessary to hasten death in order to relieve suffering. Of that 73%, only 29% indicated that they would actually perform physician-assisted suicide.
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Actitud del Personal de Salud , Docentes Médicos , Suicidio Asistido , Connecticut , Femenino , Humanos , Masculino , Persona de Mediana Edad , Suicidio Asistido/legislación & jurisprudencia , Encuestas y CuestionariosRESUMEN
BACKGROUND: Pediatric craniofacial surgeons face specific ethical and professional concerns regarding the growth of social media use in plastic surgery. The authors sought to elucidate parents' views on social media use by pediatric craniofacial surgeons. In addition, the study examines issues of consent, assent, and exploitation. METHODS: An anonymous, 51-question, multiple-choice survey investigating parents' views of pediatric plastic surgeons' social media use was crowdsourced through Prolific.Co. RESULTS: A total of 681 parents responded to the survey. Of the 656 included respondents, 88% to 93% believe that surgeons need to obtain consent from the parents to post pictures of the pediatric patient on social media, regardless of age. Respectively, 84.5% and 75% of respondents believe the surgeon needs to document assent from the 12- and 10-year-old patient. Parents who follow plastic surgeons on social media are more likely to agree that assent needs to be documented from all pediatric patients, regardless of age, before posting pictures on social media. The mean age at which respondents believe physicians should be required to elicit assent from the pediatric patient to post pictures was 9.65 years. Approximately 40% of respondents felt that patients portrayed in pictures on social media were being exploited, irrespective of the child's stated age. CONCLUSIONS: Plastic surgeons need to recognize parents' perceptions regarding social media use when considering posting pictures of pediatric patients on social media. The data suggest that surgeons should elicit assent from patients as young as 9 years before posting pictures on social media.
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Procedimientos de Cirugía Plástica , Medios de Comunicación Sociales , Cirujanos , Cirugía Plástica , Humanos , Niño , PadresRESUMEN
Before antibiotics, cardiopulmonary resuscitation (CPR), and life-sustaining technologies, humans had little choice about the timing and manner of their deaths. Today, the medicalization of death has enabled patients to delay death, prolonging their living and dying. New technology, the influence of the media, and medical professionals themselves have together transformed dying from a natural part of the human experience into a medical crisis from which a patient must be rescued, often through the aggressive extension of life or through its premature termination. In this paper, we examine problematic forms of rescue medicine and suggest the need to rethink medicalized dying within the context of medicine's orientation to health and wholeness.