14 Innovation

When we began our fetal surgery program at St. Louis Children’s Hospital, I was gratified to see how many faculty members volunteered to become inaugural members of the team. This was the first fetal surgery program at Washington University and one of the first in the country, with an uncertain trajectory and no guaranteed future professional benefit for the participants. Even so, I believe many of our faculty perceived the challenge of being part of a groundbreaking clinical program as an opportunity to participate in a novel realm of medicine. Perhaps each physician felt they would grow professionally and ultimately benefit from contributing to the development of an innovative program with a multidisciplinary team of similarly motivated physicians and nurses. As a medical educator, the innate ability of younger colleagues to adapt and innovate has been a constant source of inspiration for my own continuing education.

In a fetal surgery program, each case is unique and must be carefully evaluated based upon a traditional risk-benefit analysis to determine if the risk of the procedure to the mother and fetus is justified by the possible benefit to the fetus and soon-to-be newborn. The earliest procedures were designed to address life-threatening fetal congenital malformations compressing the airway. When done as an ex-utero intrapartum treatment (EXIT) procedure, the uteroplacental circulation of the mother provides circulatory support for the fetus while the procedure is being performed. There has been a recent expansion of the scope of lifesaving procedures to include the in-utero repair of severe congenital diaphragmatic hernias and debilitating malformations such myelomeningocele. By its nature, fetal surgery is a multidisciplinary and collaborative program that includes physicians and nurses from the disciplines of the respective surgical subspecialty performing the procedure as well as pediatric and obstetric anesthesiology, neonatology, obstetrics, and other pediatric subspecialties such as pediatric cardiology. Experience and advances in the performance of fetal surgical procedures has gradually expanded the scope and potential impact of EXIT procedures.

When our fetal program was still a new collaboration at our Institution, we received a referral for a parturient at 34 weeks estimated gestational age (EGA) who was carrying a baby with a large mass in his chest that was compressing the airway, lungs, heart, and major vessels leaving the heart. This mass was felt to be consistent with a large congenital infantile fibrosarcoma that would be incompatible with life at the time of delivery without an intervention to secure the airway and relieve the compression on the heart, vessels, and lungs. An EXIT procedure was scheduled to be performed at 37 weeks EGA with a plan to secure the airway and, if possible, partially or completely remove the mass while on uteroplacental circulation.

At 36 weeks EGA, when there was decreased fetal movement detected on the ultrasound, it was felt that the EXIT procedure would need to be performed emergently. Team members were assembled quickly, and the mother was brought into the operating room. The multidisciplinary team had scheduled additional preparatory sessions to finalize plans for what would be a novel and quite complicated procedure, so the team was not completely unprepared when the timing changed. Still, any procedure performed as an emergency increases the incidence of complications leading to a higher rate of morbidity and mortality.

Despite the team’s best efforts to maintain uteroplacental circulation during the early stages of the procedure, separation of the placenta during the debulking stage resulted in massive blood loss and hemodynamic instability, necessitating delivery of the child with a transition to an adjacent cardiothoracic operating room for resuscitation following cardiac arrest. A published case report describes this sequence of events in detail. What is not well-documented in the case report are the heroic efforts of team members to focus on the child, trust each other’s expertise, and improvise. As a facilitator of this EXIT procedure and subsequent reviewer of the case, I remain impressed by the creative efforts and collaboration of the team to care for a mother and her child.

This procedure would not have been possible a generation ago without innovations in the understanding of fetal development and maternal physiology or without technological advances in surgery and anesthesiology practice. Of equal importance has been the added emphasis in medical training on physicians developing communication and collaboration skills when working as members of a multidisciplinary team to creatively problem-solve. Perhaps most reaffirming of the merit of innovation is the picture of a beautiful and healthy infant several months after this novel procedure. I believe physicians are innately empathetic and ultimately motivated to innovate to provide better care for their patients.

Creative problem-solving is an essential skill for physicians. A foundation of modern quality assessment and improvement programs is continuous review of clinical practice, including policies and clinical guidelines that impact practice. Best practices in clinical care are continuously being revised based on a review of the best scientific evidence and clinical outcome data. A novel application of a traditional medical therapy is sometimes required to treat a rare or unusual clinical condition. For example, it is not uncommon in such cases for a physician to prescribe an unapproved “off label” medication or utilize an unconventional treatment protocol. This is accepted medical practice when conventional treatment options are limited for a specific patient but the scientific evidence supports the potential efficacy of a novel care plan based on experience treating patients with similar conditions.

Individualized “N of 1” clinical protocols are commonly conducted to create unique treatment plans that leverage the best available scientific evidence. This type of practice is often done in collaboration with others who provide consultation and implement similar novel treatment protocols for their own patients in the absence of standardized clinical guidelines. This approach to clinical care for patients with rare conditions also provides an opportunity for innovation and creating new ways of engaging patients in their healthcare decisions. By considering common findings across multiple “N of 1” studies using consistent methodology, investigators can determine whether certain treatment protocols are effective in a broader population of patients with similar rare conditions.

It is now possible to trace a patient’s health status continuously via a variety of activity applications on smart watches and cell phones. While Holter monitors have been used for decades to document and diagnose cardiac arrhythmias, advancements in remote monitoring technologies will provide physicians and researchers more opportunities to conduct both individual “N of 1” studies and larger clinical trials more conveniently and at a lower cost. Moreover, the growing use of telemedicine to evaluate and care for individuals in clinics and to enhance medical care in emergency rooms and critical units promises to raise the standard of care in medically underserved areas.

Figure 1. Creative problem-solving

Future healthcare challenges will no doubt inspire innovative solutions that leverage advances in science and technology. While the public can help identify these challenges, physicians need to lead efforts to creatively problem-solve (Figure 1). The COVID-19 pandemic provided real-time challenges and opportunities to advance preventative medical practice, such as leveraging breakthroughs in mRNA technology to generate vaccines against the COVID virus. In addition, there was the creation and implementation of treatment protocols to improve clinical outcomes when managing respiratory failure, such as the early use of steroids to decrease the inflammatory response during COVID infections and novel strategies surrounding mechanical ventilation to improve oxygenation and minimize lung injury. Clinical outcomes were also improved by practicing selective permissive hypoxemia in patients with respiratory failure diagnosed with COVID-19, avoiding early intubation and the associated adverse mental and physical trauma resulting from sedation and prolonged ventilation.

Healthcare systems and providers have also discovered that many outpatient clinic visits can be performed remotely, and the added convenience and efficiency of this option contributes to high patient satisfaction. In the aftermath of the COVID-19 pandemic, it is notable that physicians and institutions have retained many of these innovations, as they have provided value to society with increased patient satisfaction while lowering the cost of healthcare without compromising quality. In the future, the cost savings and added value of any change in clinical practice need to be weighed against any potential negative impacts on clinical outcomes and patient satisfaction. For both patients and practitioners to accept a novel practice, education describing the benefits of such changes is required. Peer-reviewed studies confirming the cost savings and positive impact of an innovation on clinical outcomes need the permanent buy-in of physicians and patients. Physicians should lead these efforts to confirm the efficacy of innovation for patients, colleagues, and third-party payers.

COVID-19 also forced medical educators to innovate in real time when the risk of viral transmission in the classroom and during teaching rounds was too high. As with the early adoption of telemedicine for the virtual care of patients, the acceptance of virtual learning was almost instantaneous. Both teachers and learners adopted this new paradigm as not only necessary but also in some instances preferable. There were also collaborations between institutions to create shared content. Faculty and trainees were dedicating long hours to their clinical practice caring for COVID patients, and they knew they could learn more if they brought all their knowledge together. Many high-fidelity simulation modules were converted to screen-based learning sessions, which was a great innovation at the time. Learner and teacher satisfaction remains high for many virtual learning sessions in the aftermath of the COVID pandemic. The acceptance of virtual teaching has given medical educators greater flexibility to be creative with their instruction and learners more self-determination with customizing their acquisition of knowledge and skills based on their learning style and the availability of resources.

The Surgical Council on Resident Education (SCORE) is an example of a collaboration involving multiple organizations, including the American Board of Surgery, American College of Surgeons, and Association of Program Directors in Surgery, to develop a comprehensive virtual curriculum to enhance and supplement the education of surgery residents. Learning modules are provided, as is access to textbooks and multimedia resources. Given their convenience and value for individual training programs, we can expect these types of collaborative learning environments to become more widely available across specialties and subspecialties.

At the height of the COVID pandemic, applicants to medical schools and residency programs were asked to interview virtually to minimize the risk of infection associated with travel and face-to-face interviews. Following the COVID crisis, the American Association for Medical Colleges (AAMC) directed medical colleges to continue their virtual interview format so that applicants could continue to benefit from the convenience and cost savings. It is notable that a short-term challenge provided an opportunity to introduce a permanent paradigm shift. The transition to virtual platforms, as in the case of interviews, medical education, and telemedicine for patient care, was transformative.

Undergraduate and postgraduate medical education programs are now incorporating curriculums focused on promoting innovation in clinical practice and research. An important feature of these programs is highlighting exemplars who provide leadership in this realm of science and medicine as well as mentor others through experiential learning activities focused on creative problem-solving. The overarching mission of these curriculums is to nurture the development of physician leaders who advance science and medicine by discovering and implementing novel solutions to future healthcare challenges. Apple founder Steve Jobs once said, “Innovation distinguishes between a leader and a follower.” Medical education programs need to encourage physicians toward the path of leading innovation.