Variations Between Hospitals in Antireflux Procedures in Children

ARTICLE Variations Between Hospitals in Antireflux Procedures in Children

Adam B. Goldin, MD, MPH; Michelle Garrison, PhD; Dimitri Christakis, MD, MPH

Objective: To examine the differences and trends in nonincidental appendectomies, 14 895 pyloromyoto- pediatric antireflux procedures (ARPs) across individual mies, and 23 527 gastrostomy tube placements were pediatric hospitals over time. identified. The average number of ARPs per appendectomy, pyloromyotomy, and gastrostomy tube place- Design: Retrospective cohort study. ment declined annually across free-standing pediatric institutions. When these annual changes are examined Setting: Administrative database containing inpatient within each hospital individually, however, it appears records with discharge dates between January 1, 2001, that such changes are not occurring equally, in that and March 31, 2006. some hospitals are performing significantly greater and some significantly fewer ARPs relative to these common Participants: Hospitalized pediatric patients younger procedures. than 18 years with primary procedure codes for ARP, appendectomy, pyloromyotomy, and gastrostomy tube Conclusions: The number of ARPs being performed in placement. The comparisons with admissions for these 36 free-standing children’s hospitals is decreasing each common procedures were used to identify changes in the year relative to several operations commonly performed incidence of ARP per hospital per year. at these institutions. Despite this overall annual de- Main Outcome Measures: The ratio of ARPs to ap- crease, there is tremendous variation between indi- pendectomies, pyloromyotomies, gastrostomies, and all vidual hospitals in how frequently ARPs are being per- 3 procedures combined, in each hospital by year. formed relative to these procedures.

Results: During our study period 13 691 ARPs, 41 441 Arch Pediatr Adolesc Med. 2009;163(7):658-663

ASTROESOPHAGEAL RE- performed. A recent study examining na- flux disease (GERD), the tional trends in the use of ARP, however, pathologic and sympto- concluded that the indications for ARPs matic reflux of gastric have “evolved during the laparoscopic era,” content into the esopha- in that fewer operations are performed on gus, affects about 7% of infants in the first neurologically impaired children or on G1,2 7 year of life. The indication for referral children after infancy. A recent study used for surgical therapy for GERD is most com- the Nationwide Inpatient Sample coupled monly a failure to respond to medical man- with census data to identify national popu- agement, though some are also referred lation-based trends with respect to ARP. based on their medical comorbidities for Citing a study that demonstrated varia- prophylactic procedures, given the per- tion between individual hospitals and na- Author Affiliations: ceived natural history and risks associ- tional trends, the authors also stated that Department of General and ated with these underlying problems.3 they were not able to address how local Thoracic Surgery, Seattle Antireflux procedures (ARPs) are com- variations in the use of ARP may affect in- Children’s Hospital mon in children and are being performed fants and children.8 (Dr Goldin); Child Health with increasing frequency.3,4 Many stud- While on the macrolevel it is ex- Institute, University of ies described excellent outcomes after ARP, tremely helpful to identify the national Washington (Dr Garrison); and with greater than 90% resolution of symp- trend in the rate of ARPs, it raises many the Center for Child Health, 5,6 Behavior, and Development, toms and improved quality of life. Given questions. Among them is whether this Seattle Children’s Hospital the prevalence of GERD and the reported trend is universal or if it is specific to a re- Research Institute, Seattle, success of ARP, it is not surprising that, gion, hospital, group practice, or even to Washington (Drs Garrison and historically, it has been described as one an individual surgeon. While a moderate Christakis). of the most common surgical procedures amount of variation in practice patterns be-

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©2009 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 tween local groups or individuals is expected, large varia- PATIENTS tions might suggest either similarly large variation in the indications for the operation or in the preoperative assess- Our study included pediatric patients younger than 18 years with ment and decision making. This is important, in that to iden- discharge dates between January 1, 2001, and March 31, 2006. tify valid measures of outcomes of an intervention like ARP The primary sample included all patients with procedure codes beyond universal measures such as death or length of stay, for ARP (ICD-9 procedure codes 44.66-44.67). Comparison samples were drawn for patients meeting the same age and date we must first identify the indications. For example, if chil- criteria, with procedure codes for appendectomy, pyloromy- dren have an ARP for aspiration pneumonia, it would be otomy, and gastrostomy; individual patients may be represented ideal to identify a cessation of events of aspiration pneu- in more than 1 category, although this was rare. Unique patient monia after the operation. A recent article demonstrated identifiers were used, however, to ensure that an individual pa- that when evaluating ARPs by more specific disease- tient only counted toward a category for the first admission, even related outcomes such as rate of hospitalizations for GERD- if subsequent admissions occurred with the same procedure code. related diagnoses like aspiration pneumonia, some children were hospitalized more frequently after compared with VARIABLES OF INTEREST before.9 No published articles to date describe clustered or re- Other variables examined included demographic characteris- gional prevalence of regurgitation or GERD and, simi- tics (age, sex, Medicaid status), hospital stay characteristics (year larly, no data suggest clustered or regional severity of dis- of discharge, length of stay, intensive care unit use, laparoscopic procedures), and relevant comorbid conditions. ease. Given the lack of demonstrable clustering of the presence or severity of GERD across the United States, STATISTICAL ANALYSIS if the indications for ARP are standard, one would ex- pect that ARPs would be performed equally often in pe- The distribution of collected variables was described across each diatric hospitals nationwide. Our hypothesis, therefore, of the operative categories. The ratio of antireflux operations is that a critical evaluation of the incidence of ARPs should to each of appendectomy, pyloromyotomy, and gastrostomy pro- not exhibit regional or clustered patterns. The aim of this cedures were then calculated by year at the hospital level. As study is to examine differences in the annual rate of pe- only one-fourth of the data were available for 2006, ratios were diatric antireflux operations across individual pediatric only calculated for the years 2001 through 2005. The distri- hospitals over time. bution of ratios across hospitals was then examined, calculat- ing the median, range, and interquartile range. To test for changes in the procedures over time within the METHODS hospitals, a series of linear regression analyses were performed with hospital as a fixed effect. The unit of analysis for We performed a retrospective examination of pediatric hospi- these regressions was a given year of data within an individual tal discharge data relevant to antireflux operations. Issues ex- hospital, and the coefficient for the discharge year was exam- plored included differences across hospitals and trends over time. ined. Again, only data for the years 2001 through 2005 were Hospital-level denominator data were not feasible given the included for these analyses, as the outcome of interest was the absence of clearly defined catchment areas for admissions to total number of antireflux operations for the year. Four regres- free-standing children’s hospitals. As a result, we used com- sion models were tested, controlling for (1) the number of parisons with admissions for other relatively common gastro- appendectomy procedures during the year for each hospital, intestinal surgical procedures as a proxy, assuming that the re- (2) the same for pyloromyotomy and (3) gastrostomy, and ferral patterns and incidence of these comparison operative (4) including the annual figures for all 3 procedures. These analy- procedures should remain relatively stable within institutions ses allowed us to estimate the annual change in the number of over time. For example, as the incidence of appendicitis in chil- antireflux procedures across hospitals. dren would be expected to stay relatively constant over the study In a secondary post hoc analysis, we used the KID data with period, a decrease in the ratio of antireflux operations to ap- population-based sample weights to estimate the total proportion pendectomy procedures within a hospital would suggest a drop ofpediatricadmissionsforeachprocedurethatwerecapturedwithin in the frequency of antireflux operations. the PHIS database, with the aim of adding context to the overall findings. Unique patient identifiers were not available within the public-use KID data files, however, so repeat admissions of the DATA SOURCE same child within a category could not be excluded. This study was approved by the institutional review board We used the Pediatric Health Information System (PHIS) da- at the Children’s Hospital and Regional Medical Center in Se- tabase developed by the Child Health Corporation of America attle, Washington. that includes demographic, diagnostic, and charge data from 36 freestanding, noncompeting children’s hospitals.10 These hospitals include private as well as University pediatric ter- RESULTS tiary referral centers. The PHIS includes diagnosis and procedure codes using the International Classification of Diseases, During our study period, 13 691 ARPs, 41 441 noninciden- Ninth Revision, Clinical Modification (ICD-9-CM) format. In a tal appendectomies, 14 895 pyloromyotomies, and 23 527 secondary post hoc analysis, we also examined the incidence gastrostomy tube placements were identified. More than half of antireflux operations in the Healthcare Cost and Utilization Project Kid’s Inpatient Database (HCUP KID) for the year of the patients undergoing each operation were male 2000. The sole purpose of this post hoc analysis was to esti- (Table 1). Of the patients undergoing an ARP, 48% had mate the overall proportion of pediatric antireflux operations at least 1 hospital day in the intensive care unit during their performed in the United States that are included in the PHIS hospitalization. Thirty-nine percent of the ARP population database. had a diagnostic code consistent with a neurologic condi-

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Percentage

Characteristic Antireflux Appendectomy Pyloromyotomy Gastrostomy Admissions, No. 13 691 41 441 14 895 23 527 Demographic characteristics Male 57 60 82 55 Age 0-1 mo 15 1 41 22 2-11 mo 32 1 58 31 1-4 y 28 10 1 25 5-11 y 14 53 0.3 12 12-17 y 9 35 0.2 9 Medicaid 50 32 48 50 Hospital stay characteristics Year of discharge 2001 20 16 18 17 2002 19 17 18 18 2003 19 19 18 19 2004 19 20 20 20 2005 18 22 21 21 2006 (Q1) 4 5 5 5 Median length of stay, d 9 2 2 16 ICU use 48 6 11 55 Procedure was laparoscopic 11 52 NA NA Comorbid conditions Neurologic condition or developmental delay 39 1 1 42 Chromosomal anomaly 6 0.1 0.3 7 Cardiopulmonary 23 0.8 3 28 Asthma 9 4 0.1 6 Aspiration pneumonia and other respiratory problems 33 0.6 3 34 Barrett esophagus 0.1 0 0 Ͻ0.1 Tracheoesophageal fixation or atresia 8 0.1 0.5 9 Diaphragmatic hernia 12 0.1 0.4 4 Hiatal hernia 1 Ͻ0.1 0.1 0.4 Intestinal fixation 3 1 0.4 4 Failure to thrive 50 1 6 67 Infants Ͻ1 y 59 18 5 66 Prematurity 8 0.3 2 12 Infants Ͻ1 y 17 19 2 22

Abbreviations: ICU, intensive care unit; NA, not applicable; Q1, first quarter. a Overlap in patients exists across all 4 categories.

tion or developmental delay, 33% had a diagnosis of aspi- pendectomy, pyloromyotomy, and gastrostomy place- ration pneumonia, and more than half had failure to thrive. ment by individual hospitals, we identify considerable Barrett esophagus was associated with 0.1% of patients. Of interhospital variability in these ratios (Figure 1). Each note, though only 11% of patients were identified as hav- dot on these graphs represents an individual hospital ing had an operation performed laparoscopically, an ICD-9 within PHIS. We do not observe a strong correlation be- code specific to this approach was only introduced in late tween the numbers of ARPs performed per year per hos- 2004. In the years following for which we have data in PHIS, pital relative to the other control procedures. 44% of cases were performed laparoscopically. The regression analyses demonstrated that the fre- Between 2001 and 2005, the average number of ARPs quency with which ARPs are being performed in free- per appendectomy, pyloromyotomy, and gastrostomy tube standing pediatric hospitals is significantly decreasing over placement declined annually across free-standing pedi- time relative to appendectomies, pyloromyotomies, and atric institutions (Table 2). For example, the 2001 ra- gastrostomy placement (Table 3). Within each hospi- tio of ARP to appendectomy was 0.36, declining to 0.26 tal, an average of 2.9 fewer ARPs are being performed each in 2005. This change is indicative of either a decrease in year relative to the number of appendectomies (PϽ.01), the number of ARPs, an increase in the number of ap- and more than 4 fewer relative to the number of pylo- pendectomies, or a combination of both. Similarly, the romyotomies and gastrostomy tube placements each ratio for pyloromytomy declined from 0.96 to 0.76, and (PϽ.001). When these annual changes are examined that of gastrostomy tube placement from 0.67 to 0.47. within each hospital individually, however, it appears that The repetition of the decline across ratio categories sug- such changes are not occurring equally everywhere gests that a true decrease in ARP rates was taking place. (Figure 2). At one extreme, one of the hospitals is per- When we visually examine the frequency of ARP per ap- forming over 40 fewer ARPs per year relative to the num-

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©2009 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 Table 2. Ratios of Antireflux Operations vs Other 200 Gastrointestinal Procedures Across Hospitals

Procedure Median Interquartile 150 by Year Ratio Range Range

Appendectomy 0.26 0.06-2.01 0.21-0.58 100 2001 0.36 0.11-3.21 0.23-0.63 2002 0.33 0.04-1.90 0.21-0.59 ARP Volume, No. ARP Volume, 2003 0.28 0.07-2.33 0.20-0.55 50 2004 0.29 0.04-2.00 0.19-0.57 2005 0.26 0.04-1.58 0.13-0.48 0 Pyloromyotomy 0.85 0.13-2.24 0.60-1.18 0 200 400 600 800 2001 0.96 0.25-2.70 0.61-1.23 Appendectomies, No. 2002 0.93 0.10-2.40 0.57-1.28 2003 0.93 0.14-3.00 0.65-1.22 200 2004 0.84 0.09-2.61 0.56-1.10 2005 0.76 0.10-1.95 0.55-1.07 150 Gastrostomy 0.61 0.08-1.10 0.36-0.76 2001 0.67 0.12-1.86 0.43-0.88 2002 0.61 0.04-1.35 0.29-0.88 100 2003 0.62 0.11-1.18 0.34-0.81 2004 0.54 0.06-1.11 0.35-0.84 ARP Volume, No. ARP Volume, 2005 0.47 0.06-1.01 0.35-0.62 50

0 ber of appendectomies, pyloromyotomies, and gastros- 050100 150 200 tomy tube placements per year, whereas at the other Pyloromyotomies, No. extreme, one of the hospitals is performing over 10 more 200 ARPs relative to these common procedures.

In a post hoc analysis, we used the KID data to esti- 150 mate the proportion of pediatric admissions for these procedures nationwide that were captured by the PHIS database. As the KID database is not available for every year, 100 the closest comparison was between the 2000 KID data ARP Volume, No. ARP Volume, and the 2001 PHIS data. Assuming no significant change 50 over the single year, we can estimate that the PHIS da-

tabase captured 37% of all Nissens, 8% of all appendec- 0 tomies, 13% of laparoscopic appendectomies, 24% of py- 0 100 200 300 400 loromyotomies, and 36% of gastrostomies placed in Gastrostomy Tube Placements, No. patients younger than 18 years in the United States. Figure 1. Ratios of antireflux operations vs other gastrointestinal procedures by hospitals. ARP indicates antireflux procedure. COMMENT

The number of ARPs being performed in 36 free-standing Table 3. Regression Analysis of the Change in the Number children’s hospitals is decreasing each year relative to sev- of ARPs Performed Across Pediatric Hospitals per Year eral commonly performed operations performed at these Relative to 3 Other Commonly Performed Operations same institutions. Despite this overall annual decrease, there in Infants and Children is tremendous variation between individual hospitals in how frequently ARPs are being performed relative to these pro- Control Coefficient P Value cedures. These findings compel us to question our a priori Appendectomy −2.9 .005 assumptions that either (1) the prevalence and severity of Pyloromyotomy −4.3 Ͻ.001 GERD or (2) the indications for ARP are consistent across Gastrostomy −4.5 Ͻ.001 populations and between hospitals. All 3 −3.9 Ͻ.001 Prior studies have addressed the prevalence of childhood regurgitation and GERD across populations.11-13 Abbreviation: ARP, antireflux procedure. Though no environmental factors have been clearly identified as responsible for the development of GERD, there variability observed in our data are entirely due to sig- may indeed be cultural, environmental, or ethnic fac- nificant differences in each hospital’s population. In fact, tors that influence the natural history and geographic dis- we looked at variables that might be associated with hos- tribution of this disease.14,15 Most of the hospitals con- pital-level characteristics that might explain the ob- tributing to the PHIS database, however, are large referral served variation such as census region, population size centers that draw from diverse ethnic and socioeco- of each hospital’s metropolitan area, and bed size of the nomic populations, and it is therefore unlikely that the hospital. Neither region nor population were correlated

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©2009 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 measures to evaluate their efficacy.5,6,24-27 This becomes es- pecially problematic in light of the recent publication by Lee et al.20 The authors found that not only are patients hospitalized with equal frequency before and after an ARP but, more importantly, many patients who were previously without specific symptoms ended up hospitalized with that symptom postoperatively. For example, these authors found that only 3 of the 24 patients who were hospitalized with aspiration pneumonia before ARP were hospitalized after ARP with this same diagnosis. They found, however, that an additional 20 patients that had never been hospitalized for aspiration pneumonia were hospitalized for this diagnosis after their ARP. The next obvious questions in light of the marginal association between symptoms and GERD and objective studies and GERD is, what are the indications for these procedures and what measures of outcome –50–40 –30 –20 –10 0 10 20 should we use to evaluate their efficacy? Should we aim to Hospitalizations, No. relieve the specific GERD-related symptom for which an individual was referred, should we aim to relieve any GERD- Figure 2. The annual change in the number of antireflux operations in each related symptom including the one for which the patient hospital after controlling for appendectomy, pyloromyotomy, and was referred, should we focus on normalizing objective mea- gastrostomy tube placement. sures of GERD such as pH probe results, or should it be a combination of these things? with the outcome, and the association with bed size was There are several limitations to this study. First, we use not statistically significant (P=.08, with hospitals with an administrative database that does not capture all of the Ͼ350 beds more likely to exhibit a decrease). We think possible clinical data. As a result, we are using this infor- it is more likely that the indications for ARP vary signifi- mation to identify disparity in clinical practices across hos- cantly between pediatric hospitals. As ARPs are major op- pitals, to suggest the need for a more standardized approach, erations that can be associated with significant benefits and to use these associations to design better prospective as well as significant complications, these are important studies. Second, the hospitals in this database are large re- findings in that inconsistent indications may translate into ferral centers, and we cannot account for possible changes 2 possible adverse scenarios—one in which children with in referral patterns over the years of this study. We attempted unremitting GERD that would benefit from this inter- to account for this possibility by using patients who had 3 vention are not receiving it, and another in which chil- different procedures (appendectomy, pylorolyotomy, and dren undergo these operations despite having the poten- gastrostomy tube placement) as reference populations. tial benefits outweighed by the risks. Despite these limitations, this article has some im- There is much indirect evidence to support this con- portant implications. The significant disparity in the use cern. Recent studies have questioned the excellent out- of ARPs across free-standing children’s hospitals in this comes of ARP in infants and children.9,16-20 Gastroesopha- country relative to other common procedures raises the geal reflux disease is poorly understood in the pediatric question of whether too many or too few operations are population, and often a diagnosis made clinically by re- being performed. There is little doubt that infants and porting of subjective symptoms rather than objective evi- children benefit from both medical and surgical inter- dence.1 Additionally, the symptoms leading to the diag- ventions for GERD. It is a disease that is driven clini- nosis can vary significantly with age and underlying cally by symptoms that are variable and diverse, such as medical conditions.21 Though several articles have linked pain, aspiration, acute life-threatening events, apnea, and objective studies with the reported symptoms, use of these failure to thrive, each of which is often poorly specific studies preoperatively is neither universal nor standard- to GERD, and each of which is not clearly associated with ized, as it is in adults.22 In fact, a publication reviewing a positive objective study. If the variability between hos- more than 7000 ARPs performed in 7 major hospitals over pitals is due to variability in the indications, then our next 20 years demonstrates that the most frequent objective task is to clarify the indications for ARPs. We need to measure of reflux used preoperatively was upper gastro- clarify the association between symptoms and the dis- intestinal series, and was performed in 68% of the popu- ease. We need to identify which objective studies will con- lation. The next most commonly used study was a pH firm the presence of GERD, and the relationship be- probe, used in 54% of patients.5 In terms of the clarity of tween specific symptoms and each of these objective the link between subjective symptoms and objective mea- studies. We need to develop disease-specific and popu- sures of GERD in children, another recent study dem- lation-specific measures of not only the quality of life of onstrated that only 52% of children evaluated for symp- patients, but also measures of the impact of GERD on the toms suggestive of GERD had a positive pH test, which patient and family (S. C. Acierno, et al, unpublished data, has been considered the diagnostic gold standard.23 December 2008). Only then will we be able to identify Though many articles have been written describing the measures of outcomes appropriate and specific to this excellent outcomes after these operations, most are based population. This should be done by identifying a cohort on subjective measures of outcome, and few use objective of patients referred for GERD-related symptoms, and pro-

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©2009 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 spectively following up this group through a diagnostic 7. Lasser MS, Liao JG, Burd RS. National trends in the use of antireflux procedures for children. Pediatrics. 2006;118(5):1828-1835. and therapeutic algorithm that will carefully record un- 8. Safadi BY, Kown M, Wren S. Utilization of laparoscopic antireflux surgery at a derlying medical conditions, presenting symptoms, ob- single Veterans Affairs facility compared with the Veterans Affairs national trend. jective results, and the interactions between these vari- Am J Surg. 2003;186(5):505-508. 9. Goldin AB, Sawin R, Seidel KD, Flum DR. Do antireflux operations decrease the rate ables that might predict the optimal interventions. of reflux-related hospitalizations in children? Pediatrics. 2006;118(6):2326-2333. 10. Owner Hospitals. Child Health Corporation of America Web site. http://www.chca Accepted for Publication: November 3, 2008. .com/owner_hospitals/index.html. Accessed October 2008. Correspondence: Adam Goldin, MD, MPH, Pediatric 11. Martin AJ, Pratt N, Kennedy JD, et al. Natural history and familial relationships of infant spilling to 9 years of age. Pediatrics. 2002;109(6):1061-1067. General and Thoracic Surgery, Children’s Hospital and 12. Nelson SP, Chen EH, Syniar GM, Christoffel KK; Pediatric Practice Research Group. Regional Medical Center, M/S W-7729, PO Box 5371, Prevalence of symptoms of gastroesophageal reflux during infancy: a pediatric Seattle, WA 98105-0371 (adam.goldin@seattlechildrens practice-based survey. Arch Pediatr Adolesc Med. 1997;151(6):569-572. 13. Nelson SP, Chen EH, Syniar GM, Christoffel KK; Pediatric Practice Research Group. .org). One-year follow-up of symptoms of gastroesophageal reflux during infancy. Author Contributions: Study concept and design: Goldin, Pediatrics. 1998;102(6):E67. Garrison, and Christakis. Acquisition of data: Goldin, 14. Osatakul S. The natural course of infantile reflux regurgitation: a non-Western perspective. Pediatrics. 2005;115(4):1110-1111. Garrison, and Christakis. Analysis and interpretation of 15. Osatakul S, Sriplung H, Puetpaiboon A, Junjana CO, Chamnongpakdi S. Preva- data: Goldin, Garrison, and Christakis. Drafting of the manu- lence and natural course of gastroesophageal reflux symptoms: a 1-year cohort script: Goldin. Critical revision of the manuscript for impor- study in Thai infants. J Pediatr Gastroenterol Nutr. 2002;34(1):63-67. 16. Hassall E. Antireflux surgery in children: time for a harder look. Pediatrics. 1998; tant intellectual content: Goldin, Garrison, and Christakis. 101(3 pt 1):467-468. Statistical analysis: Goldin, Garrison, and Christakis. Ob- 17. Hassall E. Decisions in diagnosing and managing chronic gastroesophageal re- tained funding: Goldin and Christakis. Administrative, tech- flux disease in children. J Pediatr. 2005;146(3)(suppl):S3-S12. 18. Hassall E. Outcomes of fundoplication: causes for concern, newer options. Arch nical, and material support: Goldin and Garrison. Study Dis Child. 2005;90(10):1047-1052. supervision: Garrison and Christakis. 19. Poets CF. Gastroesophageal reflux: a critical review of its role in preterm infants. Financial Disclosure: None reported. Pediatrics. 2004;113(2):e128-e132. 20. Lee SL, Shabatian H, Hsu JW, Applebaum H, Haigh PI. Hospital admissions for respiratory symptoms and failure to thrive before and after Nissen fundoplication. REFERENCES J Pediatr Surg. 2008;43(1):59-65. 21. Carson JA, Tunell WP, Smith EI. Pediatric gastroesophageal reflux: age-specific indications for operation. Am J Surg. 1980;140(6):768-771. 1. Rudolph CD, Mazur LJ, Liptak GS, et al; North American Society for Pediatric 22. 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