Care Levels for Fetal Therapy Centers.

Fetal therapies undertaken to improve fetal outcome or to optimize transition to neonate life often entail some level of maternal, fetal, or neonatal risk. A fetal therapy center needs access to resources to carry out such therapies and to manage maternal, fetal, and neonatal complications that might arise, either related to the therapy per se or as part of the underlying fetal or maternal condition. Accordingly, a fetal therapy center requires a dedicated operational infrastructure and necessary resources to allow for appropriate oversight and monitoring of clinical performance and to facilitate multidisciplinary collaboration between the relevant specialties. Three care levels for fetal therapy centers are proposed to match the anticipated care complexity, with appropriate resources to achieve an optimal outcome at an institutional and regional level. A level I fetal therapy center should be capable of offering fetal interventions that may be associated with obstetric risks of preterm birth or membrane rupture but that would be very unlikely to require maternal medical subspecialty or intensive care, with neonatal risks not exceeding those of moderate prematurity. A level II center should have the incremental capacity to provide maternal intensive care and to manage extreme neonatal prematurity. A level III therapy center should offer the full range of fetal interventions (including open fetal surgery) and be able manage any of the associated maternal complications and comorbidities, as well as have access to neonatal and pediatric surgical intervention including indicated surgery for neonates with congenital anomalies.

A comprehensive primer of surgical informed consent.

Informed consent plays a major role in forming a therapeutic alliance with the patient. The informed consent process has evolved from simple consent, in which the surgeon needed only to obtain the patient's permission for a procedure, into informed consent, in which the surgeon provides the patient with information about clinically salient features of a procedure, the patient understands this information adequately, and the patient voluntarily authorizes the surgeon to perform the procedure. Special circumstances of informed consent include conflicting professional opinions, consent with multiple physicians, patients who are undecided or refuse surgery, patients with diminished decision-making capacity, surrogate decision making, pediatric assent, and consent for the involvement of trainees.

Informed consent: it's not just signing a form.

Informed consent plays a major role in forming a therapeutic alliance with the patient. The informed consent process has evolved from simple consent, in which the surgeon needed only to obtain the patient's permission for a procedure, into informed consent, in which the surgeon provides the patient with information about clinically salient features of a procedure, the patient understands this information adequately, and the patient voluntarily authorizes the surgeon to perform the procedure. Special circumstances of informed consent include conflicting professional opinions, consent with multiple physicians, patients who are undecided or refuse surgery, patients with diminished decision-making capacity, surrogate decision making, pediatric assent, and consent for the involvement of trainees.

Ethical dimensions of elective primary cesarean delivery.

Cesarean deliveries are among the most common surgical procedures performed in the United States. Recent publications demonstrate the reduced risks of these operations and describe their potential benefits to both mothers and children. Recent surveys show that a substantial minority of obstetricians would accede to patients' requests for elective primary cesarean delivery, and some of these professionals would prefer that mode of delivery for themselves or their partners. However, scant attention has been paid to the ethical underpinnings of surgery by choice in these circumstances or ethically justified criteria for determining the role of patient choice in elective surgery generally. We define and elaborate upon the role of beneficence-, autonomy-, and justice-based considerations in these deliberations. We conclude that beneficence-based clinical judgment still favors vaginal delivery. Additionally, we have no confidence that either offering or performing elective cesarean delivery is consistent with substantive-justice-based considerations and conclude that there is no autonomy-based obligation to offer cesarean delivery in an ethically and legally appropriate informed consent process. Physicians should respond to patient-initiated requests for such procedures with a thorough informed consent process and request that the woman reconsider to ensure that her autonomy is being meaningfully exercised. In such cases, implementing a woman's request is ethically permissible.