The right stuff - Journal of Pediatric Surgery
Transcription
The right stuff - Journal of Pediatric Surgery
Journal of Pediatric Surgery 49 (2014) 1–12 Contents lists available at ScienceDirect Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg APSA Presidential Address The right stuff Keith T. Oldham, MD a r t i c l e i n f o Article history: Received 30 August 2013 Accepted 30 September 2013 a b s t r a c t We will discuss a new initiative of the American College of Surgeons and the American Pediatric Surgical Association to prospectively define optimal resource standards for children's surgical care. © 2014 Elsevier Inc. All rights reserved. Key words: Children's surgery Outcomes Quality Optimal resources Dr. Sato, Members, Guests, Ladies and Gentlemen: I am deeply honored to stand before you today in this role. This possibility did not occur to me when I attended my first American Pediatric Surgical Association (APSA) meeting as a senior fellow 30 years ago this month. I am indebted to all of you, the APSA members for your trust in me and for the opportunity afforded by my election to this position. Tom, I am grateful for that kind and personal introduction. I am privileged to have met 40 of my 43 predecessors; many have become friends. I am indeed humbled to join this group. Like all of them I expect, this moment has been on my mind since I learned of my election more than 2 years ago. By way of preparation, I have read or listened to all of the available APSA presidential addresses, as well as others. I conclude that I have license to talk about the things most important to me. Many of you know that I am generally careful to separate personal and professional interests, but today with your indulgence, I plan to speak about the people closest to me and about some issues I believe most important to us. I will speak of friends, including colleagues and mentors; of family, this will be difficult for me; and of children’s surgery, our shared professional passion. With regard to children’s surgery and APSA, I will outline a current initiative designed to optimize surgical 0022-3468/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpedsurg.2013.09.021 resources to fulfill the vision that every child undergoing surgery today receive care in the right environment to yield the best outcome; the environment you would seek for your own child if necessary. Some of you were at this morning’s APSA business meeting and know of this, but many of you were not. I will present the rationale, selected relevant data (some old, some new) and the proposal itself. I view this as a process, actually a moment in a longer journey, and I would like us to take a step together today at this 44th APSA Annual Meeting. In my predecessors’ presidential addresses, many topics have been discussed, sometimes many in a single address. Today, I would like to provide a single and I hope memorable focus and agenda for each of you and all of us. When Dr. Shamberger passed the gavel to me at this meeting last year, I indicated that I had a specific vision. I think surgeons are generally good at achieving clearly defined goals, whether it means mastering an operation, becoming a pediatric surgeon, or reaching some other finish line or mountaintop. I have spent this presidential year in pursuit of the vision I noted a moment ago and I hope to make it our collective goal. To be clear, I know there will be something less than unanimity regarding the initiative we will discuss. I am confident however that it will benefit our patients demonstrably and also our members in the long run. I believe therefore, it is the right thing to do. 1. Friends This moment at the podium is not an individual achievement. Like my predecessors, I have benefited enormously from many individuals who have given kindly and generously of their time, personal experience and wisdom to help me at every step in my professional journey. Charles Scudamore [1] observed in his presidential address to the North Pacific Surgical Association in 2011 that one trades one’s youth to become a surgeon. I have been fortunate to make this trade with the support and guidance of a remarkable group of mentors and colleagues. It is not possible to acknowledge all if we're to complete today’s activities on time; I would like to mention several however. 2 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 As a medical student, my first clinical rotation was on a surgery service at the Hunter Holmes McGuire VA Hospital in Richmond, Virginia, named to honor the Civil War surgeon who cared for Stonewall Jackson after he was mistakenly shot by his own Confederate troops. The historians in the audience will recall that the outcome was death after a survivable wound treated in a suboptimal environment. One of my attending surgeons was Dr. Hunter H. McGuire, III, who for reasons that remain a mystery to me, chose to become a mentor and also advocate on my behalf to the newly appointed young Chairman of the Department of Surgery, Dr. Lazar Greenfield. Both then and subsequent as a new and not quite as young Chairman of Surgery at the University of Michigan where I was on the faculty, Dr. Greenfield provided guidance, opportunity and personal support for me. The advice and mentorship of both men contributed critically at key moments in my journey here today. During residency I was influenced by many people of course, but none more than Dr. Kaj Johansen. Kaj, who is in the audience today, is not a pediatric surgeon, rather a vascular surgeon. We first met at Harborview Medical Center and the University of Washington in Seattle when he joined the faculty and I was a junior resident. He subsequently became the training program director and for years was highly influential in the training of many surgeons, including a number who are members of this organization. Kaj and I have shared much and have run literally thousands of miles together. When returning with Kaj on a Washington State ferry from one such race, predictably competitive and a bit painful as I recall, we had a conversation resulting in my decision to enter the pediatric surgery match that year. Although we have both slowed, he more than I, he is a best friend, an honest critic and always a competitor. In fellowship, I was privileged to train with Dr. Lester Martin, APSA President-elect at the time. The faculty included Drs. Martin, Jens Rosencranz, Joe Cox and John Noseworthy; each of whom tolerated, taught and supported me. John Noseworthy was a young faculty member with whom I became close and Dr. Fred Ryckman was my partner in fellowship the last year of my training, a year that I think we collectively made the most difficult of Dr. Martin’s long and remarkably distinguished career. As a young faculty member at the University of Michigan, I was reunited with Dr. Greenfield who I have mentioned, but worked most closely with Drs. Arnie Coran, Theo Polley and John Wesley. I learned a great deal from each of them during a critical period of professional transition from young and unfocused to a midcareer academic pediatric surgeon. Dr. Coran, of course, became President of this organization as well. All remain close friends and valued colleagues. I would like to offer my thanks as well to two other pediatric surgeons, both of whom also became Presidents of this organization, neither of whom I worked with in the clinical realm. Dr. Marc Rowe, for reasons that again remain obscure to me, concluded that I had some potential in pediatric surgery and offered particular guidance and support to me as a developing academic pediatric surgeon. The other is Dr. David Tapper about whom I will say more in a moment. Their personal mentorship and leadership by example were invaluable to me and I know to others here today. Lastly, I want to recognize and thank our entire pediatric surgical team at the Children’s Hospital of Wisconsin. The faculty members are shown in Fig. 1. I am extremely fortunate and proud to have as colleagues this group of talented, thoughtful and compassionate surgeons. As important, each is a personal friend in whom I have absolute trust and confidence: Drs. David Gourlay, Casey Calkins, Marj Arca, John Densmore, Amy Wagner, Tom Sato, Dave Lal and John Aiken. The training program we have built is a source of pride for all of us. As you know, the relationship between faculty and trainees in pediatric surgery is unique and lifelong. I have benefited enormously from my association with our trainees over the years; they did the work and I took the credit. I am confident of their individual skills and proud to have had a role in the professional development of each. Fig. 1. Drs. David Gourlay, Casey Calkins, Marj Arca, John Densmore, Amy Wagner, Tom Sato, Dave Lal, and John Aiken. 2. Family As Dr. Sato suggested, I grew up in a military family. My father was an Army AirCorps and then Air Force pilot until I finished high school. If I had to select a single person who has most influenced me, it is my father. I am not the first to suggest that pilots and surgeons share many traits, but I have known this for a very long time. A family’s support is of course crucial to us all; mine was a very close nuclear family as we moved about the world throughout my childhood. My father is shown here at the time of his flight training in February 1942 (Fig. 2A), and then he with my mother (Fig. 2B) on the occasion of their 50th wedding anniversary. Neither can be here today. My father is in hospice care in Virginia and unable to travel. We lost my mother about 4 ½ years ago. They were married 66 years, an extraordinary relationship between two remarkable and remarkably different individuals. Together they provided the foundation for me and for my siblings, allowing us to both succeed and fail in a home of unquestioned love and quiet support. It has been observed that one’s personality is shaped more by siblings than by parents. I don’t know whether that is true; I’m certain it is not quantifiable. Regardless, I certainly learned from and was influenced powerfully by my siblings. Ours was and is a highly competitive but very close family. My older brother, Tim, is the proverbial rocket scientist, a physics PhD who spent most of his career with the Defense Department and NASA. My gentle sister Marilyn is an architect who currently cares for our father. My precocious younger brother Dwight and I graduated from medical school in the same class. He is a now a senior medical oncologist in Virginia. My youngest brother Mitch is most succinctly described as a computer person. Karen and I have two boys. Our oldest son Christian is here today, a graduate of Davidson College and currently a graduate student in environmental sciences. In recent years he has been my companion, teammate, tentmate, ropemate on some adventures that I (and I think he) will never forget (Fig. 3A). His younger brother Brian (Fig. 3B) would love to be here with us, but to his distress is in the midst of final exams in a premed undergraduate curriculum. Some of you may know that OIdham is the name of an unappealing town near the epicenter of the Industrial Revolution in England. It is our family’s ancestral home. Mindful of this heritage and our current residence, I will repeat the observation once made that in England the son is defined by the father, but in America the father is defined by the son. I know this will be true for Brian and I. I am immeasurably proud of both boys. My wife, Karen Guice is known to many of you; she helped train some of you in general surgery (Fig 4A/B). In many (perhaps most) gatherings I am best known for being Mr. Guice. Karen has had an K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 3 Fig. 2. (A) Richard T. Oldham, February, 1942. (B) Richard T. and Gladys A. Oldham, 1992. extraordinary career, first in academic surgery, becoming a Professor of Surgery at Duke; currently in the Defense Department in Washington, DC where her portfolio is the U.S. military health system. Karen and I have spent almost 10 years of our marriage in different cities, raising our boys, maintaining our relationship and adapting to moderately complex professional and personal demands. While this has had its moments, our marriage as residents in Seattle remains for me the best decision I ever made. We will celebrate our 32nd wedding anniversary 5 days hence. She has been a wonderful wife, mother, companion, collaborator, partner, and friend without whom this would be neither possible nor worthwhile for me. 3. The right stuff Tom Wolfe published a book entitled The Right Stuff in 1979, the year of that ferry boat conversation I mentioned [2]. The book became a best seller and in the year I finished pediatric surgery training, 1983, was the basis for a popular movie about the Mercury 7 program and astronauts, as I expect many of you know. It profiled the individuals in some of their heroic and not so heroic moments, but it also detailed the time, team, environment and culture surrounding this effort. We are not going to discuss spaceflight today, but I have borrowed the title because I believe it is relevant to today’s proposal. If you Google™ “The Right Stuff,” many references appear related to the book and the movie. However, if you look a bit further into the Oxford Dictionary, you will see “the right stuff” refers to the “necessary qualities for a given task or job.” If you continue, you will find that the noun “stuff” specifically refers to “matter, materials, articles” and lastly to “things in which one is knowledgeable and experienced,” as in “he knows his stuff.” All of these are essential aspects of our discussion today about prospectively defining the optimal surgical environment for children. Dr. Sato touched upon my personal travels and today I would like to comment briefly about my time as a resident in Seattle. To be clear, it was a time of transformation for me, as for most in this room from a student and observer to a professional with personal accountability. With the license this occasion permits, I will digress for a moment. For me, this was also a time when my nascent interest in mountains and mountaineering became a decades-long passion in which I still Fig. 3. (A) Christian R. Oldham, 2006. (B) Brian T. Oldham, 2007. 4 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Fig. 4. (A) Karen S. Guice MD, 1993. (B) Left to right: LTG Thomas Travis, Air Force Surgeon General; LTG Patricia Horoho, Army Surgeon General; Karen Guice MD, MPP, Principal Deputy Assistant Secretary of Defense (Health Affairs); VADM Mathew Nathan, Navy Surgeon General, 2013. indulge modestly, within the limits of life as a not so young pediatric surgeon and father (Fig. 5). At that time in Seattle, there were many famous and accomplished mountaineers, including a number in the medical community, some of whom I got to know. In 1976, there was a successful American expedition to Everest involving some Seattlebased physicians; in 1978 the first successful American ascent of K2 was led by Seattle climbers. Our own pediatric surgeon, Dr. Rob Schaller at the Children’s Hospital in Seattle was an accomplished Himalayan veteran and member of this successful 1978 K2 team [3]. Dr. Tom Hornbein, even then a legendary climber, was Chairman of the Department of Anesthesia. For those of you who are interested, 50 years ago this month, he and Willie Unsoeld first climbed the West Ridge of Everest with a summit traverse and bivouac that are today still considered among the most remarkable mountaineering achievements in history [4]. Among trainees and young faculty, Dr. Bob Schoene and others I knew went on to distinguished careers and mountaineering legacies. One of the stories I learned in those days resonates with me still and does, I think, have commonality with our pediatric surgery world. Although well known in the mountaineering community, I will guess that some of you may not know of these events. Very briefly, in August 1953, just a few months after Edmund Hillary and Tenzing Norgay summited Mt. Everest for the first time, an American team was high on K2, the second highest, but widely believed to be the most difficult and dangerous mountain on earth. The team was not far from the summit under the leadership of Dr. Charles Houston, a remarkable physician scientist himself [5]. One of the team members, Art Gilkey, developed deep venous thrombosis, no doubt a consequence of the polycythemia that accompanies high altitude adaptation. He collapsed, presumably from a pulmonary embolus at about 25,000 feet and was no longer ambulatory. To be clear, individual self-sufficiency in these circumstances is generally a prerequisite for survival. The team came to his aid, abandoned the summit, endured a storm for days, organized an evacuation and began to descend with Gilkey belayed on an improvised litter over treacherous and steep terrain in unbelievably difficult circumstances. Still near 25,000 feet, one of the members fell, taking with him not only his own ropemate, but eventually five individuals on three tangled ropes. As they accelerated down the icy, precipitous slope, one of the team, Pete Schoening, saw the unfolding events, recognized that tragedy was imminent and acted. He plunged his ice ax into the snow and ice, anchored himself behind a rock, and was alone able to arrest all of the five falling members of the team, as well as hold Art Gilkey. The individuals involved each fell between 150–300 feet and had a variety of injuries. All survived with the exception of Art Gilkey, who although roped to anchors, disappeared while the other team members were regrouping. To this day, it is unclear whether this was accidental or whether this was an act of self-sacrifice to unburden his teammates and allow them to survive themselves. So in this brief story, we have the right training, the right judgment, the right response to a life-threatening situation, the right equipment for the environment and the right team working together selflessly to adapt, improve and alter the outcome. It is doubtless evident to you that I believe there are parallels in mountaineering and this story to the surgical world in which we live. I submit that the right combination of people, temperaments, acquired skills and equipment is “the right stuff” in both worlds. Most would acknowledge Drs. William Ladd and Robert Gross to be the fathers of pediatric surgery in North America. The passage below is from the introduction to their seminal text Abdominal Surgery of Infancy and Childhood published in June, 1941 [6]. They point out the suboptimal outcomes when the medical environment does not recognize the specific needs of children undergoing surgery, noting that “mortality rates in the young were extraordinarily high at the turn of the previous century and that if improved results were to be expected, the infant or small child could not be treated as though he were a diminutive man or woman.” Although the care we offer individuals today is very different than that available in 1941 and we Fig. 5. Mt. Foraker, Alaska, 2008 (Christian R. Oldham). K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 routinely do things that Drs. Ladd and Gross could only dream of, I suggest to you that even now in the 21st Century, when one looks across our entire population, we do not uniformly match care in an optimal environment with an individual child’s need. I suspect everyone in this room has his or her individual anecdotes. I’ll tell you one of mine briefly. Several years ago, we received a child in transfer from another institution, a scenario we all know. It was a toddler who had sustained blunt abdominal trauma, seen initially in a good adult centered institution. The child was awake, alert and physiologically stable. The evaluation at that institution was positive for intraperitoneal blood which led to laparotomy, uncontrolled hemorrhage and ultimately liver resection. There were systems issues I’ll not detail here today. He arrived to us subsequent with an acquired hypoxic brain injury, severed common bile duct and lesser issues, all of which he survived, but at enormous cost and with a life permanently altered. We all recognize issues in this story; most are not so dramatic. Perhaps it will never happen again, but I submit to you that we can and should do better in matching the needs of individual children to the right environment for their surgical care. Although we don't know the scope of this issue with precision, I will show you some preliminary data that suggest it is not trivial. In the interest of time, I have chosen one provocative bit of new data. I am indebted to Drs. Li Ern Chen and Robert Haley for providing these data; they are not yet published but soon will be [7]. Drs. Adam Goldin, Fizan Abdullah, Shawn Rangel and others have contributed additional important data supporting the initiative we will discuss. These data are derived from the KID 2009 data set, a national sampling of inpatient hospital discharges for infants and children in the United States (Fig. 6). It has all the inherent limitations of a large administrative dataset, including here, unproven assumptions about available hospital resources. Very importantly, this analysis does include prospective risk adjustment for patients using a novel propensity scoring methodology. The study cohort is neonates who underwent noncardiac thoracic and abdominal index operations (tracheoesophageal fistula repair, necrotizing enterocolitis related procedures and so forth, routinely performed by members of this organization) with a projected mortality of N5%. Note by comparison, that the ACS Pediatric NSQIP overall neonatal surgical mortality is approximately 2.5% at 30 days, so this is a particularly high-risk cohort at one end of the complexity spectrum. On the vertical axis is the ratio of observed to expected mortality. A value of one reflects expected performance, for our golfers, par for the course; observed mortality is the same as that expected. Above the line is not what you would want for your child, excess mortality probability; below the line are better than expected outcomes. On the horizontal axis are hospital type and 5 Fig. 7. Vision. volume. On the left are (adult) general hospitals, in the center are children’s units in general hospitals and on the far right are children’s hospitals. Within each of these left to right, we move from lower volume to higher volume as measured by annual pediatric discharges. The assumption which I believe to be plausible, is that low-volume adult general hospitals will have fewer children’s specific resources than high-volume children’s units or freestanding children’s hospitals. The resources are of course mostly specialty trained people across the spectrum of contemporary care. At the far left, in the lowest-volume general hospitals we have substantial excess mortality over that expected. If you examine the (green) statistical trend line, that effect is diminished somewhat but still noteworthy. On the far right are children’s hospitals, where you have significant survival advantage conferred. Where would you have your newborn child or family member receive this complex surgical care if needed? Perhaps this observation is not a surprise to you, but let me show you where neonates in this cohort actually received their care. Using the same database, the same cohort and the same institutional stratification as outlined above, approximately 35% of these infants received their surgical care in 2009 in the environment with a mortality probability higher than expected based on patient risk factors. This is shown in Fig. 6 by the (red) oval. I would like to propose today the vision that every child in need of surgical care in North America be treated in an environment with resources appropriate to his or her individual need. If we can do that, it will become a model applicable elsewhere, perhaps worldwide. It is an exceedingly simple vision that I believe is the right thing for us to do (Fig. 7). I’d like to turn once again to Dr. Tapper. Many of you in this room knew David; he was APSA’s President in 2000–2001. Although he trained in Boston and elsewhere, he was Surgeonin-Chief for most of his career at what is now Seattle Children’s Hospital, from 1983 until his premature death. I came to know David well because we served together in APSA. His presidential address in May 2001 was entitled “The Achievement of Audacious Goals” [8]. He discussed his remarkable personal journey through illness and he spoke of pediatric surgery calling it “the business of preserving and improving human life.” Audacious; he said “it grabs you in the gut”…”everybody knows what it means”… bold, daring, imprudent, venturesome. He went on to define 4 very specific “audacious” goals. Goal 1 ■ All children with a presumed diagnosis of intussusception should be rapidly transferred to a pediatric institution. Goal 2 ■ All children 7 years of age and younger should be operated on only by specialty certified pediatric surgeons. Goal 3 Fig. 6. O/E mortality for surgical neonates with intrinsic risk of mortality N5%. ■ All children under 4 years of age who require surgery should be anesthetized by pediatric anesthesiologists or specialists trained in pediatric anesthesia. 6 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Goal 4 ■ Health care for children is a right and should be funded. We need to become loud, visible, forceful advocates for children at local, regional and national levels. While there are some differences in the details of these David Tapper audacious goals and today’s proposal, both are absolutely consistent with the concept of providing children’s care in the right environment and with the right stuff. Let me suggest that today’s proposal is a step in this journey begun by Drs. Ladd and Gross, furthered by Dr. Tapper, and advanced by many others. It is the process of improving children’s surgical care, a goal to which we are all committed. Let me rapidly summarize some data which in aggregate offer compelling support for today’s proposal I think. Of necessity, I will be brief and selective. I invite you to examine the original data which are referenced. 4. Pediatric anesthesia Specialized pediatric anesthesia is a crucial part of our contemporary care environment. This was the subject of a more robust Education Day presentation from our Outcomes Committee in which the question was posed, “Are pediatric anesthesiologists required for better outcomes?” Their conclusion and mine is clearly yes [9–27]. My personal view is that in many ways, an excellent pediatric anesthesiologist offers a “Pete Schoening”-like lifeline for our patients when things become chaotic as they frequently do in our world. To be clear, much of this is not new information. Going back several decades to the work of Dr. Keenan, it’s been known that the risk of anesthesia is disproportionately higher in younger patients (Table 1). His original data show more than a 3-fold higher risk of anesthesia-related cardiac arrest in pediatric patients, here defined as children under the age of 12 years [27]. Today, the risk of anesthesiarelated cardiac arrest remains approximately 10-fold higher in a neonate and 5-fold higher in an infant less than 1 year of age, compared to an adult [15]. Furthermore, the risk of perioperative death is approximately 25%–30% should this occur. A subsequent report by Dr. Keenan demonstrated and others confirmed that this risk could be significantly reduced by deployment of specialty trained pediatric anesthesiologists. [19,9,24,25] (Table 2). To move to less threatening but more common events, Mamie and colleagues [13] from Geneva demonstrated meaningful reduction of perioperative adverse respiratory events in children when pediatric anesthesiologists provide care (Fig. 8); they found this to be particularly noteworthy for otolaryngology procedures, commonly performed by nonspecialized providers today in the United States. The 1989 National Confidential Enquiry into Perioperative Deaths was a landmark system review by the National Health System (NHS) in the UK [26]. The key relevant conclusion of that report for today’s discussion was that “surgeons and anesthetists should not undertake occasional pediatric care.” A more recent (2010) policy statement from the Royal College of Anaesthetists offers different verbiage but a similar conclusion; “anesthesia services for children require specialty trained clinical staff together with equipment, facilities and environment” [24]. A report from France demonstrates a strong inverse correlation between annual case volume and complication rates in pediatric anesthesia [14]. Auroy and colleagues [14] demonstrate fivefold more complications when fewer than 100 pediatric anesthetics were performed annually compared to more than 200 annually (Fig. 9). Their conclusion was, “we recommend a minimum case load of 200 pediatric anesthesia cases per year to reduce the incidence of complications and improve the level of safety in pediatric practice.” This is the basis for specific recommendation we will come to momentarily. I believe that the American Academy of Pediatrics (AAP) is one of the most effective public policy voices in health care in the United States and I think this is because advocacy for children has remained their primary focus. The most recent statement from the AAP regarding guidelines for the perioperative anesthesia environment [10] states “The annual minimum case volume required to maintain clinical competence in each patient care category should be determined by the facility’s Department of Anesthesia.” So what do you suppose has actually happened on this point in the United States? While I do not have data here, I believe that significant numbers of our population of infants and children receive care without the levels of pediatric anesthesia training and experience we know to be optimal. 5. Neonatal intensive care unit (NICU) I’d like to touch quickly now on the NICU environment, an area I believe all of us view as critical in the provision of contemporary neonatal surgical care [28–34]. The most recent AAP policy statement for the NICU environment was published about 9 months ago and defines the resources recommended for an optimal care environment in 4 levels of NICUs [33]. The recommendation is that neonatal surgical patients receive care in a Level III or Level IV nursery, characterized by functional capabilities within a regionalized system of perinatal care. Level III designation requires access to pediatric surgeons, pediatric anesthesiologists and pediatric ophthalmologists; Table 1 Incidence of anesthetic cardiac arrest.27 No. of anesthetics No. of arrests Incidence (no./ 10,000) Total Adult vs. pediatric < 12 yr 163,240 27 1.7 12,712 6 4.7 > 12 yr Emergency vs. elective Emergency 150,528 21 1.4 15,300 10 6.5 Elctive Time Daytime, Monday–Friday 147,940 17 1.1 124,100 19 1.5 39,140 8 1.8 P* .014 .0001 .79 Other *Determined by Fisher's exact probability test. K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Level IV nurseries have a full range of pediatric surgical specialists and perform surgical procedures for complex conditions. A meta-analysis (Fig. 10) (based on the previous AAP guidelines in which Level III was the highest level of care) clearly demonstrates improved survival for very-low-birth-weight infants [34], including surgical infants, in a specialized environment with access to appropriate resources; the same is true for extremely low-birth-weight and very preterm infants. This is the latest in a series of such recommendations that have been made periodically since 1976 by the AAP. It is noteworthy that the initial response to regionalize NICU efforts and optimize resources in the 1980s and 1990s has stalled or even regressed in certain areas of the country. Unfortunately, the fiscal reality of current NICU reimbursement policies encourages proliferation of small NICUs and some “deregionalization” has occurred. This is in spite of what you see here, that outcomes are demonstrably superior if these resource recommendations are followed. APSA is on record in support of neonatal surgical teams and multidisciplinary centers in a 2008 position paper by Dr. Stolar and our Workforce Committee, published in the Journal of Pediatric Surgery [31]. In addition to pediatric surgeons, this statement speaks of intimate involvement and availability of other specialty trained professionals including neonatologists, perinatal specialists, pediatric anesthesiologists, pediatric radiologists and others relevant working together as a team in an appropriate facility…the right environment…the right stuff, once again. In reality, neither the AAP nor the APSA policy efforts created a mechanism to verify and document adherence to their recommendations; hence the impact to date is limited. 6. Pediatric intensive care units (PICU) Let me move now to the pediatric intensive care unit environment [35–40]. The data in Table 3 were published in 1997 in the Lancet comparing pediatric intensive care units in Trent, north central England, with those in Victoria, a state in southeastern Australia [38]. The report reflects a period when the Australian health care system had a formal system of transfer policies in place for critically ill children, effectively regionalizing such care. Trent did not; it was left to the judgment of providers and families to select the location of care. The analysis is based upon a physiologic score assigned each patient at presentation which was predictive of mortality risk. In Victoria, the number of expected deaths and actual deaths observed was identical. On the other hand, Trent had 32 excess deaths, about 75% more than expected based on the physiologic status of patients at presentation. The authors concluded at that time that “if Trent is representative of the whole country, there are several hundred deaths a year in the UK (not a third world environment), that are probably caused by suboptimal results from pediatric intensive care.” Notably, this report did effect change in NHS policies and practice. Although the system remains imperfect, it is unlikely the results would be the same in the U.K. today. In the United States today, we of course have no formal system to assign a facility based on an individual child’s need in this circumstance. The point of care is selected by families, payors, Table 2 Distribution of cases with and without anesthetic cardiac arrest. Group No arrest Arrest Total Nonpediatric anesthesiologist 2029 4 2033 Pediatric anesthesiologist 2310 0 2310 Total 4339 4 4343 P = .048 (Fisher's exact test). Data from Keenan RL, et al. J Clin Anesth, Vol 3, Nov/Dec 1991. 7 Fig. 8. Incidence and risk factors of perioperative respiratory adverse events in children undergoing elective surgery. providers and others for a variety of reasons, similar to Trent at the time of this study. The population of the United States is about 5 times that of the UK. In January 2000, a pediatric-specific task force assembled by the American Academy of Pediatrics (AAP) and the Society of Critical Care Medicine (SCCM) concluded that evidence supporting regionalized care for critically ill children was sufficiently strong to recommend its implementation [35]. Dr. Watson presented data for the United States shortly thereafter concluding that “a growing body of evidence suggests that many hospitalized and critically ill children with fatal outcomes in the United States never received the highest level of care available” [40]. To be clear, some planned and some defacto regionalization occurs in the PICU environment, but it is variable and inconsistent if assessed at a national population level. 7. Congenital heart surgery Congenital heart surgery is largely done by individuals not represented here today. I will say a word about it however, because I think it is illustrative of high complexity procedures in high-risk infants and children and the data are more clear here than elsewhere at present [41–45]. California, like most states, has more congenital heart programs than one would likely create if asked to plan prospectively. Dr. Chang evaluated their performance in a provocative report published in 2002 in which a 2-year experience with congenital heart surgery in the state of California was analyzed [45]. For better or worse, 30-day or inhospital mortality for congenital heart surgery is a meaningful, dichotomous variable reliably recorded. It is clear for congenital heart surgery that low-volume centers generally have higher mortality probability and higher volume is associated with lower mortality on a risk-adjusted basis. I will note here that we (the Children’s Hospital Association and the Organization of Children’s Hospitals Surgeons-in-Chief) recently commissioned a Cochrane Response Rapid Review on this general subject [46]. This concludes that higher volume is generally effective in reducing hospital mortality after congenital heart surgery. The Cochrane standard is rigorous, more than two-thirds of published studies show positive correlation between higher volume and lower morbidity, although the magnitude of the effect is uncertain because of disparate methodologies. To return to Dr. Chang’s report, low-volume centers are theoretically closed and patients moved, theoretically again, to the next nearest center. As one moves from left to right on the graph in Fig 11, progressively moving patients to the next nearest center, there is little 8 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Fig. 9. Relationship between complications of pediatric anesthesia and volume of pediatric anesthetics. change in the number of avoidable deaths for the first several centers closed. As you close more centers moving to the right, statewide mortality is reduced until you are left with five high-volume centers where no further benefit is apparent. More than 80 lives are saved annually in this population-based analysis; one state, congenital heart disease only. Interestingly the authors also performed concurrent analysis of the travel burden such a strategy would impose on families. The average travel distance was 45.4 miles for a child here, and this was increased by 12.7 miles when all surgeries were referred to high-volume centers as outlined. These are averages, obviously there are some for whom it is much more. We will discuss this briefly again in a moment. 8. Trauma Our adult trauma colleagues have effectively although not perfectly addressed this issue of triaging patients to receive care in the right environment [47–52]. In 1976 the Committee on Trauma of the American College of Surgeons first published a document which became Resources For Optimal Care of the Injured Patient [48]. Program characteristics were defined prospectively for various levels of trauma centers, with particular emphasis on the providers required. Importantly, this program included a verification process administered by the American College of Surgeons. As most of you know, if an institution elects to be verified as a trauma center, periodic site visits by representatives from the ACS verification team confirm that the resources delineated in this regularly updated document are actually in place. I will note that this has been a useful mechanism for providers to obtain necessary resources. It has taken several decades, and even though nearly 50 million Americans live over 1 hour away from a high level trauma center [52], it has been a demonstrably successful effort. Ellen McKenzie, PhD, demonstrated significant improvement in mortality outcomes if care is provided in the right environment, a trauma center, with survival advantage of about 20%– 25% conferred for adults with similar serious injuries [47]. A report from Australia last year shows that similar trauma system Fig. 10. Survival for very-low-birth-weight infants. K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Table 3 Regionalization of PICU Services Reduces Mortality. Victoria Trent n Deaths Expected n Deaths* 1194 60 deaths* Total 1014 74 42.3 Expected deaths* 60.0 Interpretation: If Trent is representative of the whole country, there are 453 (200-720) excess deaths a year in the UK that are probably due to suboptimal results from paediatric intensive care [38]. development and regionalization demonstrably improved not just survival, but functional outcomes for seriously injured patients as well [51]. I conclude that the preponderance of evidence supports the hypothesis that children undergoing complex procedures and those who are at high risk because of certain patient factors such as young age or comorbidities, have better outcomes in a specialized environment. Not that many individual patients will not do well in our current system; but if considered on a population basis, I believe that too many infants and children currently receive care in an environment deficient in support elements we know to be associated with better outcomes. I call your attention to the Articles of Incorporation for APSA. When the organization was founded, we committed ourselves to “establishing standards of excellence in the surgical care of infants and children” [53]. In our current strategic plan, again briefly discussed this morning at our business meeting, seven strategic directions are enumerated [54] (Table 4). To be clear, these are substantially unchanged from earlier versions of this document, although the specific goals and tasks are updated. I highlight now and for the remainder of our time, the 9 first of these directions; “Define standards for optimal health care for children that promote the quality and safety of pediatric surgery in an efficient and cost conscious manner that provides value for our patients and the health care community.” I will briefly summarize the proposal that we shared electronically with the entire membership April 1, 2013 and discussed briefly earlier today [55]. Just over 1 year ago, with the support and sponsorship of the Children’s Hospital Association and the American College of Surgeons, we convened an ad hoc group which we called the Task Force for Children’s Surgical Care. It included leadership from various pediatric surgical groups, including APSA, the AAP Section on Surgery, the Advisory Council for Pediatric Surgery of the American College of Surgeons, and also the leadership from the pediatric surgery training program directors, the Pediatric Surgery Board of the American Board of Surgery, as well as other disciplines, notably pediatric anesthesia, neonatology, cardiology and neurosurgery. The intent was to have it small enough to be functional, but large enough to be representative. Participants are documented carefully in the proposal. It is fair to say we have had several groups come forward subsequent to seek inclusion and we have done so. The focus was to stratify infants and children by clinical need and to define the optimal surgical environment; the right people, the right facilities and the right systems. We recognized that this will necessarily be a data-driven process. We outlined and assigned individual tasks for data development to examine medical quality (outcomes), as well as financial impact, travel burden and manpower needs. Some of the data I have shared today result from work assigned then and done in the last 12 months. The Task Force utilized the best available data and consensus that was presumably expert when data were lacking [56,57]. To be clear, I view this current proposal as a first edition that will be regularly modified via processes we must yet create. The proposal that I am advocating for today is entitled “Optimal Resources for Children’s Surgical Care, (we said) in the United States,” Fig. 11. Effect of theoretical closure of low volume-high mortality congenital heart programs in California. Reproduced with permission from Pediatrics 109(2):173-181, 2002 by the AAP. 10 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 Table 4 Strategic directions; American Pediatric Surgical Association. 1. Define standards for "optimal health care for children" that promote the quality and safety of pediatric surgery in an efficient and cost conscious manner to provide value for our patients and the health care community. 2. Promote education and facilitate certification for pediatric surgeons throughout their careers, from trainee to senior surgeon. 3. Encourage the discovery and dissemination of new knowledge. 4. Become a respected resource for information on new technology and innovation in the field. 5. Become a trusted source for in-depth educational information for patients and their families. 6. Formulate public policy and become an effective voice that advocates nationaly for "optimal health care for children." 7. Lead discussions on the workforce and economic environment of the field and implement necessary change. but it is more widely applicable I think. It represents the work product from this group. It was our initial intent to develop the document and publish it as an opinion piece from the individual members of the Task Force, seeking subsequent formal approval from the various relevant organizations, as we know this can be a quite lengthy process. As we moved forward, key organizations asked that we obtain organizational approval prior. I will discuss that a bit more momentarily. Our proposal is based on age criteria presently, not specific procedures; that level of detail and complexity was judged prohibitive. The choice of age thresholds is for utility but also reflects the important relationship between age and anesthesia outcomes we discussed earlier at some length. We recommend designations at Table 5 Optimal resources by center designation. three levels and somewhat arbitrarily call these “comprehensive,” “advanced” and “basic.” In addition, we included congenital heart programs. With regard to the latter, there are already reasonably detailed resource guidelines through the AAP; we made no effort to modify these [41]. We recommend that children less than 1 year of age receive optimal care in a “comprehensive” environment. Between the ages of 1 and 6 years an “advanced” environment is recommended and above the age of 6 years a “basic” environment is recommended. This will undoubtedly be refined and modified as we move forward. We defined resources; examples are shown in Table 5. To be clear, not every child under the age of 1 year will need every resource such as an NICU or PICU that is required for a comprehensive center, but access must be available when needed. We do not have time to review all of the details today, but the entire proposal is disseminated to our members and available on our Website. It is mostly access to the right team members and to the right resources at the right time. As I trust I have made clear, the pediatric anesthesia component of this is a major point. Let me go through that one example with you quickly. We defined a pediatric anesthesiologist as someone certified or eligible for certification in pediatric anesthesia by the American Board of Anesthesia or equivalent, AND who has an anesthesia case log of 200 or more patients less than 18 years of age annually, including 10 or more infants less than 1 year of age. We also defined availability. For a comprehensive center, two or more pediatric anesthesiologists must be on staff and one must be available to respond to the bedside and provide care within 60 minutes. Verification is a very important issue, as has been demonstrated clearly by the AAP process of recommending guidelines without this feature. Beyond acknowledgement of this point, we have not made specific recommendations about this at present. It will be a subject of discussion at the next Task Force meeting which is later this month. To be frank, without a mechanism for verification an initiative such as K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 11 Fig. 12. Newspaper articles regarding congenital heart surgery outcomes in Bristol, U.K.. this will have little impact I expect. Please recall the ACS-Trauma Center process and experience. It is a voluntary program, not a directive. Participation (verification) is driven by providers and communities interested in improving the quality of care and outcomes for injured patients. It has demonstrably made a difference. In summary, we have become quite facile at caring for individual patients and for certain groups in the various regions we serve. Our challenge now is less what we can do for an individual patient, but what we might do for all children. This proposal is directed at improving children’s surgical care for our entire population. The intent is improved surgical outcomes for all of our patients; it will discomfort some providers. Much work remains to be done. The proposal does not address the issue of differential outcomes in specific complex procedures such as repair of congenital diaphragmatic hernia, biliary atresia and others. As we consider less complex procedures (appendicitis, pyloric stenosis and the like) and lower-risk patients, benefit is less apparent and more data are clearly needed. I do think that his proposal defines basic infrastructure necessary for safety and is a relatively “low bar” supported by existing data. I think it can assist our members in working with hospitals, other institutions and other providers to obtain necessary resources. Although good care generally yields higher value, data will need to be developed related to economic impact as well as training, manpower and access/travel burden. We will need to Fig. 13. Hospitals with higher neonatal surgery volume have better patient outcomes 2012 APSA Member Survey (unpublished). 12 K.T. Oldham / Journal of Pediatric Surgery 49 (2014) 1–12 develop better methods to share information and export best practices where possible. Implementation will require buy-in from many and organizational processes will need to be developed. Lastly, let me note that there is ever more public scrutiny of what we do. Fig. 12 reflects the British tabloid response (on the left) when the NHS report on excess mortality in the Bristol congenital heart surgery program was made public in 2001. More recently (on the right), you see a headline and comment on the NHS and the professional resistance to recommended change over the intervening decade. Neither is what we seek professionally. There are a number of unique issues here that in the interest of time, we cannot discuss. My point is simply that I think the public will hold us accountable if we do not do what we know or believe to be best for our patients. Fig. 13 reflects what you, the APSA members thought when queried in a survey by Dr. Chen about 1 year ago on the question of neonatal regionalization and surgical outcomes. More than 70% of you indicated agreement or strong agreement with the statement that hospitals with higher neonatal surgery volume have better patient outcomes. Fewer than 10% disagreed [58]. To conclude, I have offered a rationale and a vision. I have summarized some data and made a proposal. I’ve said that this is a journey, perhaps uphill, begun by others long ago. The APSA Board of Governors has unanimously approved this optimal resources proposal as did an overwhelming majority of our members this morning. It is a part of our current strategic plan. We have the next Task Force meeting later this month as I noted. Presentation to the Regents of the American College of Surgeons is next month. There will be many more steps before it is reality. It will be ongoing and at times hard work. I do believe strongly that it will benefit infants and children with surgical needs. I am confident that we will get there, to see that all infants and children receive what they need, the right stuff. I will close by simply saying thank you for your attention today. 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