Articles Tagged With:
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Hot Trials from the European Society of Cardiology Annual Congress
Below are some highlights from four key studies presented in Barcelona, Spain, between Aug. 26 and Aug. 29, 2022, along with Dr. Crawford’s personal commentary on each.
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REVIVED Shows No PCI Benefit for Patients with Coronary Disease, Reduced EF
Researchers randomly assigned patients with an ejection fraction ≤ 35% and severe coronary disease to percutaneous coronary intervention or optimal medical therapy alone. After 3.4 years median follow-up, researchers noted no significant differences between groups in terms of all-cause death or heart failure hospitalization.
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Statins Plus Ezetimibe vs. Statins Alone
A comparison of rosuvastatin 10 mg/day plus ezetimibe (10 mg/day) to 20 mg/day of rosuvastatin alone showed non-inferiority in three-year major cardiovascular outcomes, with lower LDL cholesterol levels and fewer episodes of drug discontinuation or dose reductions in the combination therapy group.
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Importance of Discordant Grading of Moderate Aortic Stenosis
A study of patients with moderate aortic stenosis by Doppler echocardiographic calculated valve area revealed 40% exhibit discordant measures, where pressure gradient is lower than expected. These patients died more often than those with concordant measurements, especially those where the discrepancy was caused by low flow.
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Fraud Allegations Involving Alzheimer’s Disease Study Raise Concerns
In a paper published in 2006, the authors provided evidence indicating accumulation of a specific form of beta-amyloid protein was a cause of Alzheimer’s disease. However, recent accusations suggest images allegedly were altered, raising doubts about the initial conclusions. Regardless of what happened, this case has jumpstarted a conversation about instituting more preventive measures, conducting faster investigations into fraud allegations, and levying more severe consequences for researchers found guilty of misconduct.
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Ethicists Asked to Weigh in on Medical Necessity of Abortion
If ethicists are asked to weigh in, they should suggest a second medical opinion (if time permits) and encourage the institution to clarify any legal questions, ideally before there is an emergency. Institutions also should assure clinicians they will have support from the ethics committee in the event of overzealous prosecution.
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New Requirements Are Discouraging Physicians from Writing DNR Orders
Ethicists should help develop related protocols. For practitioners, code status conversations should be treated with the seriousness of surgery. That means involving the right people and taking the time to ensure medical understanding and prognosis, as well as patient values and goals, before talking about a care plan. When possible, practitioners should bring up DNR at the end of a meaningful conversation.
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Some IRBs Expand Their Purview to Consider Scientific Merit
The most common ethics-related reasons for protocol deferral were inadequate informed consent, insufficient protection of participants’ safety, inadequate detail of risk assessment, and inadequate minimization of risks. Some study protocols were not approved due to issues of scientific merit, such as adequate adverse event reporting or the importance of the knowledge to be gained. Read on to learn how to prevent these problems and avoid delays.
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Court-Appointed Guardians for Unrepresented Patients
Ethicists are seeing a range of issues arise during consults involving unrepresented patients, including conflicts over how aggressive treatment should be, whether to treat at all, how to discharge, and how to follow up with compliance with treatment. Creating a template for actions to take related to unrepresented persons who present to the hospital is a proactive first step.
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Making Ethical Decisions on Genetic Testing, Precision Medicine
Physicians are obligated to consider the benefits and harms of genetic testing. They must be prepared to engage in discussions with patients, and offer assistance in understanding the risks, benefits, and uncertainties of direct-to-consumer genetic testing. Clinicians must safeguard privacy, security, and confidentiality of patient information.