Publications by authors named "N E Kass"
Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations.
View Article and Find Full Text PDFImportance: With the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents.
Observations: US regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice.
Article Synopsis
- About 5%-10% of breast cancer cases in the U.S. are linked to genetic factors, making prophylactic mastectomy an option for those at risk.
- This study analyzed data from 506 patients with genetic predisposition to breast cancer between 2010 and 2020, finding that 30.4% chose prophylactic mastectomy, typically 1.1 years after diagnosis.
- Key factors influencing the decision included having a family member with cancer (54.7%) and personal cancer history (27.5%), which can help improve shared decision-making in healthcare.
Article Synopsis
- * Although clinical trial design has evolved, data collection infrastructure still requires heavy investment and labor, limiting the evidence available for understanding how treatments affect different patient groups.
- * The authors propose a modernized data infrastructure that promotes the integration of diverse data sources and facilitates the reuse of health data, highlighting the importance of multidisciplinary collaboration to track progress in this area.
Article Synopsis
- * The use of mixed reality (MR) technology, specifically Medivis's SurgicalAR with Microsoft HoloLens, allows surgeons to visualize and interact with 3D imaging of a patient's anatomy in real time.
- * In a study, the MR system successfully outlined patients' frontal sinuses with minimal differences compared to traditional 3D-printed guides, highlighting its potential as an effective imaging tool in gender-affirming surgeries.