Journal of Pediatric Surgery 49 (2014) 818–822
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Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Consensus Statement
Optimizing resources for the surgical care of children: An American Pediatric Surgical Association Outcomes and Clinical Trials Committee Consensus Statement Adam B. Goldin a,⁎, Roshni Dasgupta b, Li Ern Chen c, Martin L. Blakely d, Saleem Islam e, Cynthia D. Downard f, Shawn J. Rangel g, Shawn D. St. Peter h, Casey M. Calkins i, Marjorie J. Arca i, Douglas C. Barnhart j, Jacqueline M. Saito k, Keith T. Oldham i, Fizan Abdullah l a
Division of Pediatric General and Thoracic Surgery, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA 98105 Division of Pediatric General and Thoracic Surgery, Cincinnati Children’s Hospital, Cincinnati, OH 45229–3039 c Division of Pediatric Surgery, University of Texas Southwestern Medical Center, Children’s Medical Center, Dallas, TX 75235 d Department of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, TN 37232 e Division of Pediatric Surgery, University of Florida College of Medicine, Gainesville, FL 32610 f Division of Pediatric Surgery, Hiram C. Polk, Jr. M.D. Department of Surgery, University of Louisville, Louisville, KY 40202 g Department of Pediatric Surgery, Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115 h Department of Surgery, Children’s Mercy Hospital, Kansas City, MO 64108 i Department of Pediatric Surgery, Medical College of Wisconsin, Children’s Hospital of Wisconsin, Milwaukee, WI 53226 j Division of Pediatric Surgery, University of Utah, Salt Lake City, UT 84113 k Division of Pediatric Surgery, Washington University, St. Louis, MO 63110 l Division of Pediatric Surgery, Johns Hopkins University, Baltimore, MD 21287 b
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Article history: Received 20 November 2013 Received in revised form 16 February 2014 Accepted 17 February 2014 Key words: Optimization Safety Clinical outcomes Volume-related outcomes Resources Quality
a b s t r a c t The United States’ healthcare system is facing unprecedented pressures: the healthcare cost curve is not sustainable while the bar of standards and expectations for the quality of care continues to rise. Systems committed to the surgical treatment of children will likely require changes and reorganization. Regardless of these mounting pressures, hospitals must remain focused on providing the best possible care to each child at every encounter. Available clinical expertise and hospital resources should be optimized to match the complexity of the treated condition. Although precise criteria are lacking, there is a growing consensus that the optimal combination of clinical experience and hospital resources must be defined, and efforts toward this goal have been supported by the Regents of the American College of Surgeons, the members of the American Pediatric Surgical Association, and the Society for Pediatric Anesthesia (SPA) Board of Directors. The topic of optimizing outcomes and the discussion of the concepts involved have unfortunately become divisive. Our goals, therefore, are 1) to provide a review of the literature that can provide context for the discussion of regionalization, volume, and optimal resources and promote mutual understanding of these important terms, 2) to review the evidence that has been published to date in pediatric surgery associated with regionalization, volume, and resource, 3) to focus on a specific resource (anesthesia), and the association that this may have with outcomes, and 4) to provide a framework for future research and policy efforts. © 2014 Elsevier Inc. All rights reserved.
The United States’ healthcare system is facing unprecedented pressures: the healthcare cost curve is not sustainable while the bar of standards and expectations for the quality of care continues to rise. Systems committed to the surgical treatment of children will likely require changes and reorganization. Regardless of these mounting pressures, hospitals must remain focused on providing the best possible care to each child at every encounter. Available clinical ⁎ Corresponding author at: Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105, M/S W-7729, PO Box 5371, Seattle, WA 98105. Tel.: +1 206 987 3241 (Assistant); fax: +1 206 987 3925. E-mail address: [email protected] (A.B. Goldin). http://dx.doi.org/10.1016/j.jpedsurg.2014.02.085 0022-3468/© 2014 Elsevier Inc. All rights reserved.
expertise and hospital resources should be optimized to match the complexity of the treated condition. Although precise criteria are lacking, there is a growing consensus that the optimal combination of clinical experience and hospital resources must be defined, and efforts toward this goal have been supported by the Regents of the American College of Surgeons, the members of the American Pediatric Surgical Association, and the Society for Pediatric Anesthesia (SPA) Board of Directors. The topic of optimizing outcomes and the discussion of the concepts involved has unfortunately become divisive. Our goals, therefore, are 1) to provide a review of the literature that can provide context for the discussion of regionalization, volume, and optimal resources and promote mutual understanding of these important
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terms, 2) to review the evidence that has been published to date in pediatric surgery associated with regionalization, volume, and resource, 3) to focus on a specific resource (anesthesia), and the association that this may have with outcomes, and 4) to provide a framework for future research and policy efforts. 1. Historical context In 1979, Luft, Bunker, and Enthoven published a landmark article in the New England Journal of Medicine that gave birth to a new avenue of surgical research that linked volume and outcomes [1]. They proposed two hypotheses: (1) the quality of care improves with the experience of the providers, and (2) the “experience effect” should be more pronounced in more complex procedures. These two hypotheses were derived from observations described in industrial economics where experience or learning curves were “associated with a logarithmic decline in unit cost as a function of cumulative production experience.” In addition, these authors proposed that these observations could be extrapolated into the organization of medical care. If true, they asserted that “optimal quality as well as cost savings from economies of scale and experience could potentially be realized through ‘regionalization’.” Even more important than describing a relationship between volume and surgical mortality for several procedures, this article stimulated discussion that led to further research in health services, health economics, patient safety, and quality of care, while catalyzing the effort towards regionalization. It is important to note that the authors explicitly stated that the reason for the relationship between volume and outcome was not clear, but could be linked to a variety of factors at the hospital, patient, and surgeon level. Furthermore, the temporal causality of whether higher volume led to better outcomes or, conversely, whether better outcomes led to higher volume, was not clear. They concluded that further research was needed to evaluate the relative contribution of individual surgeons, operating teams, hospital staffing, and other resources on outcomes. The topic of patient safety and clinical outcomes was thrust into the public psyche by the 1999 Institute of Medicine report that attributed 44,000–98,000 deaths per year to perceived medical errors [2]. The impact of this report was profound and led to rapid implementation of new standards while the research community struggled to provide evidence to support such policy changes. One example of this complex interplay between research and rapid implementation of new standards was the Leapfrog group – a consortium of 34 large employers (e.g. General Electric, General Motors, GTE/Verizon) who viewed themselves as purchasers of healthcare [3]. They defined hospitals as suppliers much like the suppliers of any other materials needed for the day-to-day function of businesses. The group identified “Proposed Safety Standards” that recommended, among other things, that hospital referral should be based on “scientific evidence of the volume-outcome relationship” [3]. The influence and popularity of this outcomes-focused healthcare delivery philosophy had the effect of validating the volume-outcomes relationship in the eyes of the public, even though supporting evidence was still lacking. As a result, physicians and patients were encouraged to use high-volume centers under the premise that their outcomes would be better. The medical community continued to pursue evidence supporting the positive relationship between volume and outcomes. Notable among these was an article in 2001 by Birkmeyer that affirmed the Leapfrog conclusions, and described the number of lives that would be saved by implementing recommended volume standards [4]. The emphasis on volume alone was downplayed by some authors, however, who chose instead to refocus the discussion on patient safety. In the same journal edition as Birkmeyer’s article, Shukri Khuri wrote an invited commentary in which he argued that “it is not volume but systems of care that prevail in an institution that may be
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responsible for better outcomes.” [5] “At best,” he wrote, “volume is a proxy measure that has not been validated as a measure of quality of surgical care.” Shortly thereafter, Halm et al. reviewed published volumeoutcome data within adult surgery [6]. While the authors found that higher volume was associated with better outcomes across a range of procedures, the magnitude of the association was highly variable, and the complex interplay between volume, resource availability and outcomes remained poorly understood. Not one of the 135 papers reviewed accounted for the possibility that volume may fluctuate over time, and none were able to shed insight on the proxy relationship, as previously offered by Khuri. The authors did identify two basic explanations for the volume-outcome relationship: 1) physicians and hospitals develop more effective skills if they treat more patients, and 2) physicians and hospitals achieving better outcomes receive more referrals and thus accrue larger volumes. Additionally, the authors established that the volume-outcomes relationship was highly variable between surgical procedures. Given the variability in the association between volume and outcome, researchers began to investigate other factors that might influence the volume-outcome relationship such as the relative effects of individual surgeon-volume, hospital-volume, case-mix/acuity, and processes of care. In 2003, Birkmeyer et al. showed that for some procedures, the association between hospital-volume and outcome disappeared almost entirely after surgeon volume had been taken into account [7]. Shortly thereafter, Dimick et al. demonstrated that mortality, the outcome most commonly evaluated, is too rare of an event to serve as a quality indicator, and therefore, should not be used to assess surgical quality [8]. An interesting study from Health Affairs in 2003 evaluated the effects of staffing differences in low and high-volume hospitals by linking the National Inpatient Sample with the American Hospital Association Annual Survey of Hospitals [9]. While the volumeoutcome relationship was upheld in general, low-volume hospitals were noted to have fewer residents and RNs per 100 beds. After adjusting for this staffing difference, however, the authors noted that for two procedures (heart transplants and pediatric heart surgeries), low-volume hospitals with staffing comparable to higher-volume hospitals had the same outcomes. This substantiated the position that optimizing resources, such as staffing and expertise, was perhaps more important than increasing hospital volume through the process of regionalization. In pediatric surgery, much of the evidence that we use to guide our clinical decision making is extrapolated from the adult literature. We must therefore move our field forward on three fronts: 1) develop quality measures that are specific to pediatric surgical conditions, 2) generate interdisciplinary consensus on the safe delivery of pediatric surgical care in order to influence widespread policy change, and 3) identify a research plan that will provide pediatric-specific outcome data so that we may improve surgical outcomes on a national level. The question that looms before us is not whether or not to regionalize or even superregionalize pediatric surgical care, but rather to identify the resources that each hospital must have to optimize the delivery of care for infants and children. 2. Evidence The first step to achieve these objectives is to review the current state of the literature in pediatric surgery addressing the relationship between outcomes and volume as well as outcomes and access to pediatric specific expertise. McAteer and colleagues recently performed an extensive search of the MEDLINE and EMBASE databases to address this question and identified 63 articles in 7 pediatric surgical subspecialties, evaluating 25 distinct surgical procedures [10]. Because of the heterogeneity of the methodology, a meta-analysis was not feasible. There was significant variability in the expression of
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volume and outcomes measured among the articles evaluated. Some articles defined volume as a continuous variable, while others used categorical variables or thresholds. Several articles defined volume by hospital volume, while others used surgeon volume, or specialty/ subspecialty designation. Outcome variables included mortality, length of stay, readmission, hospital charges, or occurrence of complications. Nineteen percent of the papers reviewed did not risk-adjust, and of those that did, methodology was heterogeneous. Indeed, 12% of these manuscripts did not adjust for disease severity. Hereafter, we will describe the McAteer et al. findings as they relate to pediatric general surgery. The relationship between outcomes and access to pediatric specific expertise can be broken down into the following subgroups: 2.1. Specialized pediatric surgeons vs. general surgeons Four studies on appendicitis investigated whether outcomes were different when patients were treated by pediatric surgeons or general surgeons [11–14]. Three studies showed shorter lengths of stay and two revealed lower hospital charges in favor of pediatric surgeons. One report showed that patients with perforated appendicitis had lower complication rates when treated by pediatric surgeons. Another study demonstrated that pediatric surgeons had a lower negative appendectomy rate. Three studies on pyloric stenosis investigated whether outcomes were different when patients were treated by pediatric surgeons vs. general surgeons [15–17]. All three studies found that there were fewer complications when pyloromyotomy was performed by a pediatric surgeon. Length of stay was shorter for patients treated by a pediatric surgeon in two of the studies, and one noted that hospital charges were lower for patients treated by a pediatric surgeon. In summary, in children with appendicitis and pyloric stenosis, not one of these seven studies showed an advantage for treatment by a general surgeon. While appendectomy and pyloromyotomy are not technically complex procedures, pediatric surgeons were associated with better results than general surgeons. If we assume equal technical proficiency between adult general surgeons and pediatric surgeons, then the only thing that is different between these groups is the environment (and incumbent resources) in which the children are treated. 2.2. Pediatric environment and resources Three studies on appendicitis examined whether patient outcomes differed when patients were treated in a pediatric environment compared to a nonpediatric environment [18–20]. Pediatric environments were noted to be associated with a longer length of stay in two of the studies, and were associated with higher hospital charges in one of the studies. One study noted that the negative appendectomy rate and postoperative infectious complication rate were lower in pediatric environments. Two of the studies also demonstrated that patients treated in pediatric environments had lower readmission rates. Two studies on pyloric stenosis found that length of stay was shorter for patients treated in pediatric environments, and one found that hospital charges were higher for those treated in pediatric environments [18,21,22]. Not one of these studies showed an advantage for treatment in a nonpediatric environment for either appendicitis or pyloric stenosis. The McAteer study was followed by a Cochrane Response Rapid Review performed as a collaboration between five of the members of the Task Force for Children’s Surgical Care and the Cochrane group in Ottawa [23,24]. This review screened 8291 citations and identified 62 relevant articles that evaluated five principle exposure comparisons: hospital volume, surgeon volume, children’s vs. general hospitals, comprehensive pediatric vs. general hospitals, and pediatric surgeons vs. general surgeons. The papers included in this review identified
8 outcomes in the literature: mortality, length of stay, composite postoperative complications, respiratory complications, cardiac complications, postoperative infections, cost, and rates of disease-specific adverse events. This review identified that specialization within pediatric cardiac surgery was generally effective at reducing mortality. Conclusions were far less clear for noncardiac procedures. Of the 107 outcome comparisons between specialized and nonspecialized centers, including nonmortality measures, 58% suggested a significant benefit for specialization, 37% were inconclusive and 5% suggested better outcomes for nonspecialized centers. Specialization appeared to have greater benefit for more complex patients and more severe outcome measures (e.g. mortality), although the heterogeneity of included studies precluded formal statistical analysis. Since these reviews were published, Rhee and colleagues reviewed a national database and compared individual surgeons within specialties (neurosurgery, otolaryngology, cardiothoracic surgery, general surgery, orthopedic surgery, and urology) [25]. They categorized surgeons into quartiles by individual percentage of cases performed on patients under 18 years of age. The “lowest” quartile surgeons had a case mix of b 25% pediatric cases, followed by 25–50%, 51–75%, and N 75% (“highest” quartile). Using the primary outcome of mortality, the authors analyzed surgeons within each specialty, controlling for age, year, gender, insurance status, type of hospital, and hospital region. The authors identified significant differences among cardiothoracic and general surgery patients. The odds of mortality for pediatric cardiothoracic patients treated by surgeons in the lower two quartiles was greater compared to the highest quartile (1.78; p = 0.02, and 2.61; p b 0.01). Similarly, the odds of mortality for general surgery pediatric patients treated by surgeons in the lowest quartile was greater compared to the highest quartile (OR 2.15; p = 0.04). These findings suggest that at least among cardiothoracic and general surgery, surgeons whose practice is primarily pediatric compared to those who mainly treat adults achieve better outcomes in children. 3. Anesthesia Perioperative cardiac arrest has long been considered to be a seminal quality indicator of anesthetic care. In 1985, the American Society of Anesthesiologists (ASA) began the ASA Closed Claims Project to systematically review closed anesthesia malpractice claims to describe patterns of rare events and possible causes [26]. A 1993 analysis of this database demonstrated that compared to claims in adults, malpractice claims in children were more commonly for mortality (50% vs. 35%) and respiratory events (43% vs. 30%). Despite the author’s desire to identify causes of claims, unfortunately the database did not have enough detail to address these questions. For example, while the database often described “hypoxia” as the cause for both outcomes, the database did not detail underlying cause for the hypoxia. As a result, pediatric anesthesia specialists formed The PeriOperative Cardiac Arrest (POCA) Registry in 1994 to determine the incidence and causes of perioperative cardiac arrest in children under 18 years of age. An initial review of the registry identified that the majority of arrests were medication-related, specifically owing to the use of the cardiac suppressive inhalant halothane [27]. A follow-up review of this registry noted that the etiology of perioperative arrest changed to cardiovascular events unrelated to halothane [28]. Eightythree institutions contributed data to the registry during the period analyzed. Further research into adverse events in pediatric anesthesiology then turned from medications to comparisons between pediatric specialists and generalists in anesthesia. One single-institutional comparison reviewed the anesthetic records of 2310 patients whose anesthetics were supervised by pediatric-trained anesthesiologists versus 2033 cases supervised by nonpediatric anesthesiologist [29].
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There were no significant differences between baseline characteristics of patient groups. It was noted that the incidence of cardiac arrests per 10,000 anesthetics was 19.7 in the nonpediatric anesthesiologist group versus 0 in the pediatric-trained anesthesiologist group (p b 0.05), concluding that infants were significantly more likely to experience a cardiac arrest when not treated by a pediatric trained anesthesiologist. In another study focusing specifically on respiratory complications, 12.8% of 755 children were noted to have some type of event [30]. After multivariate logistic regression analysis, it was noted that a child was 1.77 times more likely to have an adverse respiratory event when under the care of a nonpediatric trained anesthesiologist compared to a pediatric specialist (95% CI: 1.12–2.57). Similar to the surgical discussion above, there appears to be a volume/outcome relationship in pediatric anesthesia as well. A review of a retrospective database identified that complications such as ineffective endotracheal intubation (failed intubation, esophageal intubation, or bronchial intubation), anesthetic drug overdose, cardiac arrest, and pulmonary aspiration were directly related to the number of pediatric cases performed annually [31]. The authors categorized anesthesia providers by annual pediatric caseload (1–100 cases per year, 100–200 cases per year, and N200 cases per year) and identified complications rates of 7, 2.8, and 1.3 events per 1000 anesthetics respectively (p b 0.05). Acknowledging the limitations of the study, the authors still recommended at least 200 pediatric anesthetics per year in order to maintain patient safety. While the precise reason for the differences in anesthetic outcomes was not clear, investigators began to look into specific characteristics in children that may play a role. One study showed that infants under one year of age were 9 times more likely than children under fifteen to have anesthetic complications [32]. Keenan et al. reviewed nearly 8000 anesthetic records and documented the incidence of bradycardia, the most common anesthetic complication noted in children that can lead to hypoxia, acidosis, and other cardiovascular complications, is higher among infants under one year of age compared to children 3–4 years of age (1.27 vs. 0.16%) [33]. This study also noted that an infant was far less likely to experience bradycardia if treated by a pediatric trained anesthesiologist after controlling for other variables (OR 0.4; 95% CI 0.24–0.69). Other factors significantly associated with poorer anesthetic outcomes in children included higher ASA class (3–5 vs. 1–2), procedures lasting longer than 4 hours, emergency procedures, underlying heart disease, and pulmonary hypertension [34]. In order to deliver optimal perioperative care to pediatric patients, the presence of well-trained, experienced pediatric anesthesiologists is essential to minimize the risk of respiratory complications, bradycardia, cardiac arrest, and death. Pediatric training in anesthesiology appears to be particularly important in complex cases, as well as in our youngest patients who are at highest risk and stand to benefit the most from care in specialized environments. There are currently 42 ACGME certified training programs in pediatric anesthesiology, with 207 fellows in the current year cohort. There have been over 1000 pediatric anesthesiologists trained in the last 10 years by a cohort of senior anesthesiologists who devoted their practice to children. In recognition of the importance of specialized training, the American Board of Anesthesiology has recently introduced board certification in pediatric anesthesiology with the first examination administered in October 2013. In order to qualify for the board examination, 30% of an anesthesiologist’s clinical practice, averaged over the last 5 years, must be devoted to pediatric cases. This also must include neonates and children under the age of 2 years, and procedures considered high-risk [35].
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quality metrics are essential to understanding where the deficits lie and how improvements can be made to ensure that all children, regardless of where they reside, receive optimal surgical care. Ideally, we would create a system in which all patients are rapidly referred to the closest institution that meets the individual patient and family needs and provides the highest quality of care as defined by outcomes. It is generally felt among pediatric healthcare practitioners that there are times when discrepancy between available resources and the many clinical needs of infants and children exists, and that this mismatch may result in suboptimal outcomes for those children. In the United States, 142 of 306 hospital referral regions currently do not have a pediatric surgeon available for bedside consultation. These regions constitute approximately 20% of the nation’s children (personal communication) [36]. We believe that it is paramount to devise a national health care strategy that will improve surgical health care for all children regardless of where they reside. While the volume-outcome relationship is well documented in adult medicine, there is growing evidence that it is not only volume, but also the resources that are available in high-volume centers that contribute to improved outcomes. We believe that the available evidence in pediatric surgery suggests similar findings. In order to have a constructive discussion of optimizing the quality of surgical care in children, we must first define the resource requirements, while addressing the discrepancy between need and resource availability. Equally important, we must develop relevant and objective quality measures in the surgical care of children. From these data we extrapolate that outcomes of simple and complex procedures in children may be improved when performed in a setting with appropriate resources. Similar to adult data, the reasons for this are likely multifactorial, with effects such as hospital environment, specialized training of nurses, surgeon expertise, and volume all playing a role in outcome. Additionally, the presence of trained pediatric anesthesiologists clearly diminishes the risk of adverse events in the care of the pediatric surgical patient, particularly those who are the youngest or have complex comorbidities. Further study is required to improve our understanding of the complexities that impact the quality of surgical outcomes in children. Our greatest hurdle will be in creating a research and outcome network that will standardize the methodology and the outcomes analyzed, and then prioritize diagnoses to be evaluated. Outcomes should be classified into two general categories; 1) generic outcomes that apply to any child exposed to a surgeon and anesthesiologist and their incumbent healthcare system such as mortality, length of stay, composite postoperative complications, respiratory complications, cardiac complications, postoperative infections, cost, and 2) outcomes that are specific to a particular operation such as duodenal perforation in pyloromyotomy. Diagnoses to evaluate could be prioritized initially by choosing a few high frequency but low resource utilization diagnoses (e.g. appendectomy, pyloromyotomy), and a few high frequency and high resource utilization diagnoses (necrotizing enterocolitis, gastroschisis, gastrostomy tube placement) and prospectively evaluate these outcomes along with qualitative indices such as travel burden, family/ parental stress, and long-term cognitive function. To be clear, our intention is not to recommend regionalization, but rather to provide surgeons with the historical context and data to advocate for optimizing resources within the systems in which they practice, and to encourage participation in quality and research networks such as the National Surgical Quality Improvement Program (NSQIP), the Pediatric Health Information System (PHIS), or Wake up Safe, in order to optimize the quality of care that we as pediatric surgeons deliver nationally.
4. Conclusion Optimization of surgical care for children is a laudable goal, but in the face of our changing health care environment, it is likely to be complex and labor intensive to achieve. Assuring quality of care and measuring
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Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Consensus Statement
Optimizing resources for the surgical care of children: An American Pediatric Surgical Association Outcomes and Clinical Trials Committee Consensus Statement Adam B. Goldin a,⁎, Roshni Dasgupta b, Li Ern Chen c, Martin L. Blakely d, Saleem Islam e, Cynthia D. Downard f, Shawn J. Rangel g, Shawn D. St. Peter h, Casey M. Calkins i, Marjorie J. Arca i, Douglas C. Barnhart j, Jacqueline M. Saito k, Keith T. Oldham i, Fizan Abdullah l a
Division of Pediatric General and Thoracic Surgery, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA 98105 Division of Pediatric General and Thoracic Surgery, Cincinnati Children’s Hospital, Cincinnati, OH 45229–3039 c Division of Pediatric Surgery, University of Texas Southwestern Medical Center, Children’s Medical Center, Dallas, TX 75235 d Department of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, TN 37232 e Division of Pediatric Surgery, University of Florida College of Medicine, Gainesville, FL 32610 f Division of Pediatric Surgery, Hiram C. Polk, Jr. M.D. Department of Surgery, University of Louisville, Louisville, KY 40202 g Department of Pediatric Surgery, Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115 h Department of Surgery, Children’s Mercy Hospital, Kansas City, MO 64108 i Department of Pediatric Surgery, Medical College of Wisconsin, Children’s Hospital of Wisconsin, Milwaukee, WI 53226 j Division of Pediatric Surgery, University of Utah, Salt Lake City, UT 84113 k Division of Pediatric Surgery, Washington University, St. Louis, MO 63110 l Division of Pediatric Surgery, Johns Hopkins University, Baltimore, MD 21287 b
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Article history: Received 20 November 2013 Received in revised form 16 February 2014 Accepted 17 February 2014 Key words: Optimization Safety Clinical outcomes Volume-related outcomes Resources Quality
a b s t r a c t The United States’ healthcare system is facing unprecedented pressures: the healthcare cost curve is not sustainable while the bar of standards and expectations for the quality of care continues to rise. Systems committed to the surgical treatment of children will likely require changes and reorganization. Regardless of these mounting pressures, hospitals must remain focused on providing the best possible care to each child at every encounter. Available clinical expertise and hospital resources should be optimized to match the complexity of the treated condition. Although precise criteria are lacking, there is a growing consensus that the optimal combination of clinical experience and hospital resources must be defined, and efforts toward this goal have been supported by the Regents of the American College of Surgeons, the members of the American Pediatric Surgical Association, and the Society for Pediatric Anesthesia (SPA) Board of Directors. The topic of optimizing outcomes and the discussion of the concepts involved have unfortunately become divisive. Our goals, therefore, are 1) to provide a review of the literature that can provide context for the discussion of regionalization, volume, and optimal resources and promote mutual understanding of these important terms, 2) to review the evidence that has been published to date in pediatric surgery associated with regionalization, volume, and resource, 3) to focus on a specific resource (anesthesia), and the association that this may have with outcomes, and 4) to provide a framework for future research and policy efforts. © 2014 Elsevier Inc. All rights reserved.
The United States’ healthcare system is facing unprecedented pressures: the healthcare cost curve is not sustainable while the bar of standards and expectations for the quality of care continues to rise. Systems committed to the surgical treatment of children will likely require changes and reorganization. Regardless of these mounting pressures, hospitals must remain focused on providing the best possible care to each child at every encounter. Available clinical ⁎ Corresponding author at: Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105, M/S W-7729, PO Box 5371, Seattle, WA 98105. Tel.: +1 206 987 3241 (Assistant); fax: +1 206 987 3925. E-mail address: [email protected] (A.B. Goldin). http://dx.doi.org/10.1016/j.jpedsurg.2014.02.085 0022-3468/© 2014 Elsevier Inc. All rights reserved.
expertise and hospital resources should be optimized to match the complexity of the treated condition. Although precise criteria are lacking, there is a growing consensus that the optimal combination of clinical experience and hospital resources must be defined, and efforts toward this goal have been supported by the Regents of the American College of Surgeons, the members of the American Pediatric Surgical Association, and the Society for Pediatric Anesthesia (SPA) Board of Directors. The topic of optimizing outcomes and the discussion of the concepts involved has unfortunately become divisive. Our goals, therefore, are 1) to provide a review of the literature that can provide context for the discussion of regionalization, volume, and optimal resources and promote mutual understanding of these important
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terms, 2) to review the evidence that has been published to date in pediatric surgery associated with regionalization, volume, and resource, 3) to focus on a specific resource (anesthesia), and the association that this may have with outcomes, and 4) to provide a framework for future research and policy efforts. 1. Historical context In 1979, Luft, Bunker, and Enthoven published a landmark article in the New England Journal of Medicine that gave birth to a new avenue of surgical research that linked volume and outcomes [1]. They proposed two hypotheses: (1) the quality of care improves with the experience of the providers, and (2) the “experience effect” should be more pronounced in more complex procedures. These two hypotheses were derived from observations described in industrial economics where experience or learning curves were “associated with a logarithmic decline in unit cost as a function of cumulative production experience.” In addition, these authors proposed that these observations could be extrapolated into the organization of medical care. If true, they asserted that “optimal quality as well as cost savings from economies of scale and experience could potentially be realized through ‘regionalization’.” Even more important than describing a relationship between volume and surgical mortality for several procedures, this article stimulated discussion that led to further research in health services, health economics, patient safety, and quality of care, while catalyzing the effort towards regionalization. It is important to note that the authors explicitly stated that the reason for the relationship between volume and outcome was not clear, but could be linked to a variety of factors at the hospital, patient, and surgeon level. Furthermore, the temporal causality of whether higher volume led to better outcomes or, conversely, whether better outcomes led to higher volume, was not clear. They concluded that further research was needed to evaluate the relative contribution of individual surgeons, operating teams, hospital staffing, and other resources on outcomes. The topic of patient safety and clinical outcomes was thrust into the public psyche by the 1999 Institute of Medicine report that attributed 44,000–98,000 deaths per year to perceived medical errors [2]. The impact of this report was profound and led to rapid implementation of new standards while the research community struggled to provide evidence to support such policy changes. One example of this complex interplay between research and rapid implementation of new standards was the Leapfrog group – a consortium of 34 large employers (e.g. General Electric, General Motors, GTE/Verizon) who viewed themselves as purchasers of healthcare [3]. They defined hospitals as suppliers much like the suppliers of any other materials needed for the day-to-day function of businesses. The group identified “Proposed Safety Standards” that recommended, among other things, that hospital referral should be based on “scientific evidence of the volume-outcome relationship” [3]. The influence and popularity of this outcomes-focused healthcare delivery philosophy had the effect of validating the volume-outcomes relationship in the eyes of the public, even though supporting evidence was still lacking. As a result, physicians and patients were encouraged to use high-volume centers under the premise that their outcomes would be better. The medical community continued to pursue evidence supporting the positive relationship between volume and outcomes. Notable among these was an article in 2001 by Birkmeyer that affirmed the Leapfrog conclusions, and described the number of lives that would be saved by implementing recommended volume standards [4]. The emphasis on volume alone was downplayed by some authors, however, who chose instead to refocus the discussion on patient safety. In the same journal edition as Birkmeyer’s article, Shukri Khuri wrote an invited commentary in which he argued that “it is not volume but systems of care that prevail in an institution that may be
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responsible for better outcomes.” [5] “At best,” he wrote, “volume is a proxy measure that has not been validated as a measure of quality of surgical care.” Shortly thereafter, Halm et al. reviewed published volumeoutcome data within adult surgery [6]. While the authors found that higher volume was associated with better outcomes across a range of procedures, the magnitude of the association was highly variable, and the complex interplay between volume, resource availability and outcomes remained poorly understood. Not one of the 135 papers reviewed accounted for the possibility that volume may fluctuate over time, and none were able to shed insight on the proxy relationship, as previously offered by Khuri. The authors did identify two basic explanations for the volume-outcome relationship: 1) physicians and hospitals develop more effective skills if they treat more patients, and 2) physicians and hospitals achieving better outcomes receive more referrals and thus accrue larger volumes. Additionally, the authors established that the volume-outcomes relationship was highly variable between surgical procedures. Given the variability in the association between volume and outcome, researchers began to investigate other factors that might influence the volume-outcome relationship such as the relative effects of individual surgeon-volume, hospital-volume, case-mix/acuity, and processes of care. In 2003, Birkmeyer et al. showed that for some procedures, the association between hospital-volume and outcome disappeared almost entirely after surgeon volume had been taken into account [7]. Shortly thereafter, Dimick et al. demonstrated that mortality, the outcome most commonly evaluated, is too rare of an event to serve as a quality indicator, and therefore, should not be used to assess surgical quality [8]. An interesting study from Health Affairs in 2003 evaluated the effects of staffing differences in low and high-volume hospitals by linking the National Inpatient Sample with the American Hospital Association Annual Survey of Hospitals [9]. While the volumeoutcome relationship was upheld in general, low-volume hospitals were noted to have fewer residents and RNs per 100 beds. After adjusting for this staffing difference, however, the authors noted that for two procedures (heart transplants and pediatric heart surgeries), low-volume hospitals with staffing comparable to higher-volume hospitals had the same outcomes. This substantiated the position that optimizing resources, such as staffing and expertise, was perhaps more important than increasing hospital volume through the process of regionalization. In pediatric surgery, much of the evidence that we use to guide our clinical decision making is extrapolated from the adult literature. We must therefore move our field forward on three fronts: 1) develop quality measures that are specific to pediatric surgical conditions, 2) generate interdisciplinary consensus on the safe delivery of pediatric surgical care in order to influence widespread policy change, and 3) identify a research plan that will provide pediatric-specific outcome data so that we may improve surgical outcomes on a national level. The question that looms before us is not whether or not to regionalize or even superregionalize pediatric surgical care, but rather to identify the resources that each hospital must have to optimize the delivery of care for infants and children. 2. Evidence The first step to achieve these objectives is to review the current state of the literature in pediatric surgery addressing the relationship between outcomes and volume as well as outcomes and access to pediatric specific expertise. McAteer and colleagues recently performed an extensive search of the MEDLINE and EMBASE databases to address this question and identified 63 articles in 7 pediatric surgical subspecialties, evaluating 25 distinct surgical procedures [10]. Because of the heterogeneity of the methodology, a meta-analysis was not feasible. There was significant variability in the expression of
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volume and outcomes measured among the articles evaluated. Some articles defined volume as a continuous variable, while others used categorical variables or thresholds. Several articles defined volume by hospital volume, while others used surgeon volume, or specialty/ subspecialty designation. Outcome variables included mortality, length of stay, readmission, hospital charges, or occurrence of complications. Nineteen percent of the papers reviewed did not risk-adjust, and of those that did, methodology was heterogeneous. Indeed, 12% of these manuscripts did not adjust for disease severity. Hereafter, we will describe the McAteer et al. findings as they relate to pediatric general surgery. The relationship between outcomes and access to pediatric specific expertise can be broken down into the following subgroups: 2.1. Specialized pediatric surgeons vs. general surgeons Four studies on appendicitis investigated whether outcomes were different when patients were treated by pediatric surgeons or general surgeons [11–14]. Three studies showed shorter lengths of stay and two revealed lower hospital charges in favor of pediatric surgeons. One report showed that patients with perforated appendicitis had lower complication rates when treated by pediatric surgeons. Another study demonstrated that pediatric surgeons had a lower negative appendectomy rate. Three studies on pyloric stenosis investigated whether outcomes were different when patients were treated by pediatric surgeons vs. general surgeons [15–17]. All three studies found that there were fewer complications when pyloromyotomy was performed by a pediatric surgeon. Length of stay was shorter for patients treated by a pediatric surgeon in two of the studies, and one noted that hospital charges were lower for patients treated by a pediatric surgeon. In summary, in children with appendicitis and pyloric stenosis, not one of these seven studies showed an advantage for treatment by a general surgeon. While appendectomy and pyloromyotomy are not technically complex procedures, pediatric surgeons were associated with better results than general surgeons. If we assume equal technical proficiency between adult general surgeons and pediatric surgeons, then the only thing that is different between these groups is the environment (and incumbent resources) in which the children are treated. 2.2. Pediatric environment and resources Three studies on appendicitis examined whether patient outcomes differed when patients were treated in a pediatric environment compared to a nonpediatric environment [18–20]. Pediatric environments were noted to be associated with a longer length of stay in two of the studies, and were associated with higher hospital charges in one of the studies. One study noted that the negative appendectomy rate and postoperative infectious complication rate were lower in pediatric environments. Two of the studies also demonstrated that patients treated in pediatric environments had lower readmission rates. Two studies on pyloric stenosis found that length of stay was shorter for patients treated in pediatric environments, and one found that hospital charges were higher for those treated in pediatric environments [18,21,22]. Not one of these studies showed an advantage for treatment in a nonpediatric environment for either appendicitis or pyloric stenosis. The McAteer study was followed by a Cochrane Response Rapid Review performed as a collaboration between five of the members of the Task Force for Children’s Surgical Care and the Cochrane group in Ottawa [23,24]. This review screened 8291 citations and identified 62 relevant articles that evaluated five principle exposure comparisons: hospital volume, surgeon volume, children’s vs. general hospitals, comprehensive pediatric vs. general hospitals, and pediatric surgeons vs. general surgeons. The papers included in this review identified
8 outcomes in the literature: mortality, length of stay, composite postoperative complications, respiratory complications, cardiac complications, postoperative infections, cost, and rates of disease-specific adverse events. This review identified that specialization within pediatric cardiac surgery was generally effective at reducing mortality. Conclusions were far less clear for noncardiac procedures. Of the 107 outcome comparisons between specialized and nonspecialized centers, including nonmortality measures, 58% suggested a significant benefit for specialization, 37% were inconclusive and 5% suggested better outcomes for nonspecialized centers. Specialization appeared to have greater benefit for more complex patients and more severe outcome measures (e.g. mortality), although the heterogeneity of included studies precluded formal statistical analysis. Since these reviews were published, Rhee and colleagues reviewed a national database and compared individual surgeons within specialties (neurosurgery, otolaryngology, cardiothoracic surgery, general surgery, orthopedic surgery, and urology) [25]. They categorized surgeons into quartiles by individual percentage of cases performed on patients under 18 years of age. The “lowest” quartile surgeons had a case mix of b 25% pediatric cases, followed by 25–50%, 51–75%, and N 75% (“highest” quartile). Using the primary outcome of mortality, the authors analyzed surgeons within each specialty, controlling for age, year, gender, insurance status, type of hospital, and hospital region. The authors identified significant differences among cardiothoracic and general surgery patients. The odds of mortality for pediatric cardiothoracic patients treated by surgeons in the lower two quartiles was greater compared to the highest quartile (1.78; p = 0.02, and 2.61; p b 0.01). Similarly, the odds of mortality for general surgery pediatric patients treated by surgeons in the lowest quartile was greater compared to the highest quartile (OR 2.15; p = 0.04). These findings suggest that at least among cardiothoracic and general surgery, surgeons whose practice is primarily pediatric compared to those who mainly treat adults achieve better outcomes in children. 3. Anesthesia Perioperative cardiac arrest has long been considered to be a seminal quality indicator of anesthetic care. In 1985, the American Society of Anesthesiologists (ASA) began the ASA Closed Claims Project to systematically review closed anesthesia malpractice claims to describe patterns of rare events and possible causes [26]. A 1993 analysis of this database demonstrated that compared to claims in adults, malpractice claims in children were more commonly for mortality (50% vs. 35%) and respiratory events (43% vs. 30%). Despite the author’s desire to identify causes of claims, unfortunately the database did not have enough detail to address these questions. For example, while the database often described “hypoxia” as the cause for both outcomes, the database did not detail underlying cause for the hypoxia. As a result, pediatric anesthesia specialists formed The PeriOperative Cardiac Arrest (POCA) Registry in 1994 to determine the incidence and causes of perioperative cardiac arrest in children under 18 years of age. An initial review of the registry identified that the majority of arrests were medication-related, specifically owing to the use of the cardiac suppressive inhalant halothane [27]. A follow-up review of this registry noted that the etiology of perioperative arrest changed to cardiovascular events unrelated to halothane [28]. Eightythree institutions contributed data to the registry during the period analyzed. Further research into adverse events in pediatric anesthesiology then turned from medications to comparisons between pediatric specialists and generalists in anesthesia. One single-institutional comparison reviewed the anesthetic records of 2310 patients whose anesthetics were supervised by pediatric-trained anesthesiologists versus 2033 cases supervised by nonpediatric anesthesiologist [29].
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There were no significant differences between baseline characteristics of patient groups. It was noted that the incidence of cardiac arrests per 10,000 anesthetics was 19.7 in the nonpediatric anesthesiologist group versus 0 in the pediatric-trained anesthesiologist group (p b 0.05), concluding that infants were significantly more likely to experience a cardiac arrest when not treated by a pediatric trained anesthesiologist. In another study focusing specifically on respiratory complications, 12.8% of 755 children were noted to have some type of event [30]. After multivariate logistic regression analysis, it was noted that a child was 1.77 times more likely to have an adverse respiratory event when under the care of a nonpediatric trained anesthesiologist compared to a pediatric specialist (95% CI: 1.12–2.57). Similar to the surgical discussion above, there appears to be a volume/outcome relationship in pediatric anesthesia as well. A review of a retrospective database identified that complications such as ineffective endotracheal intubation (failed intubation, esophageal intubation, or bronchial intubation), anesthetic drug overdose, cardiac arrest, and pulmonary aspiration were directly related to the number of pediatric cases performed annually [31]. The authors categorized anesthesia providers by annual pediatric caseload (1–100 cases per year, 100–200 cases per year, and N200 cases per year) and identified complications rates of 7, 2.8, and 1.3 events per 1000 anesthetics respectively (p b 0.05). Acknowledging the limitations of the study, the authors still recommended at least 200 pediatric anesthetics per year in order to maintain patient safety. While the precise reason for the differences in anesthetic outcomes was not clear, investigators began to look into specific characteristics in children that may play a role. One study showed that infants under one year of age were 9 times more likely than children under fifteen to have anesthetic complications [32]. Keenan et al. reviewed nearly 8000 anesthetic records and documented the incidence of bradycardia, the most common anesthetic complication noted in children that can lead to hypoxia, acidosis, and other cardiovascular complications, is higher among infants under one year of age compared to children 3–4 years of age (1.27 vs. 0.16%) [33]. This study also noted that an infant was far less likely to experience bradycardia if treated by a pediatric trained anesthesiologist after controlling for other variables (OR 0.4; 95% CI 0.24–0.69). Other factors significantly associated with poorer anesthetic outcomes in children included higher ASA class (3–5 vs. 1–2), procedures lasting longer than 4 hours, emergency procedures, underlying heart disease, and pulmonary hypertension [34]. In order to deliver optimal perioperative care to pediatric patients, the presence of well-trained, experienced pediatric anesthesiologists is essential to minimize the risk of respiratory complications, bradycardia, cardiac arrest, and death. Pediatric training in anesthesiology appears to be particularly important in complex cases, as well as in our youngest patients who are at highest risk and stand to benefit the most from care in specialized environments. There are currently 42 ACGME certified training programs in pediatric anesthesiology, with 207 fellows in the current year cohort. There have been over 1000 pediatric anesthesiologists trained in the last 10 years by a cohort of senior anesthesiologists who devoted their practice to children. In recognition of the importance of specialized training, the American Board of Anesthesiology has recently introduced board certification in pediatric anesthesiology with the first examination administered in October 2013. In order to qualify for the board examination, 30% of an anesthesiologist’s clinical practice, averaged over the last 5 years, must be devoted to pediatric cases. This also must include neonates and children under the age of 2 years, and procedures considered high-risk [35].
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quality metrics are essential to understanding where the deficits lie and how improvements can be made to ensure that all children, regardless of where they reside, receive optimal surgical care. Ideally, we would create a system in which all patients are rapidly referred to the closest institution that meets the individual patient and family needs and provides the highest quality of care as defined by outcomes. It is generally felt among pediatric healthcare practitioners that there are times when discrepancy between available resources and the many clinical needs of infants and children exists, and that this mismatch may result in suboptimal outcomes for those children. In the United States, 142 of 306 hospital referral regions currently do not have a pediatric surgeon available for bedside consultation. These regions constitute approximately 20% of the nation’s children (personal communication) [36]. We believe that it is paramount to devise a national health care strategy that will improve surgical health care for all children regardless of where they reside. While the volume-outcome relationship is well documented in adult medicine, there is growing evidence that it is not only volume, but also the resources that are available in high-volume centers that contribute to improved outcomes. We believe that the available evidence in pediatric surgery suggests similar findings. In order to have a constructive discussion of optimizing the quality of surgical care in children, we must first define the resource requirements, while addressing the discrepancy between need and resource availability. Equally important, we must develop relevant and objective quality measures in the surgical care of children. From these data we extrapolate that outcomes of simple and complex procedures in children may be improved when performed in a setting with appropriate resources. Similar to adult data, the reasons for this are likely multifactorial, with effects such as hospital environment, specialized training of nurses, surgeon expertise, and volume all playing a role in outcome. Additionally, the presence of trained pediatric anesthesiologists clearly diminishes the risk of adverse events in the care of the pediatric surgical patient, particularly those who are the youngest or have complex comorbidities. Further study is required to improve our understanding of the complexities that impact the quality of surgical outcomes in children. Our greatest hurdle will be in creating a research and outcome network that will standardize the methodology and the outcomes analyzed, and then prioritize diagnoses to be evaluated. Outcomes should be classified into two general categories; 1) generic outcomes that apply to any child exposed to a surgeon and anesthesiologist and their incumbent healthcare system such as mortality, length of stay, composite postoperative complications, respiratory complications, cardiac complications, postoperative infections, cost, and 2) outcomes that are specific to a particular operation such as duodenal perforation in pyloromyotomy. Diagnoses to evaluate could be prioritized initially by choosing a few high frequency but low resource utilization diagnoses (e.g. appendectomy, pyloromyotomy), and a few high frequency and high resource utilization diagnoses (necrotizing enterocolitis, gastroschisis, gastrostomy tube placement) and prospectively evaluate these outcomes along with qualitative indices such as travel burden, family/ parental stress, and long-term cognitive function. To be clear, our intention is not to recommend regionalization, but rather to provide surgeons with the historical context and data to advocate for optimizing resources within the systems in which they practice, and to encourage participation in quality and research networks such as the National Surgical Quality Improvement Program (NSQIP), the Pediatric Health Information System (PHIS), or Wake up Safe, in order to optimize the quality of care that we as pediatric surgeons deliver nationally.
4. Conclusion Optimization of surgical care for children is a laudable goal, but in the face of our changing health care environment, it is likely to be complex and labor intensive to achieve. Assuring quality of care and measuring
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