- Email: [email protected]
Outcomes research in pediatric surgery
Journal of Pediatric Surgery (2011) 46, 221–225
www.elsevier.com/locate/jpedsurg
Outcomes research in pediatric surgery Part 1: overview and resources ☆ Fizan Abdullah a,⁎,1 , Gezzer Ortega a , Saleem Islam b,1 , Douglas C. Barnhart c,1 , Shawn D. St. Peter d,1 , Steven L. Lee e , Loretto Glynn f,1 , Daniel H. Teitelbaum g,1 , Marjorie J. Arca h,1 , David C. Chang i a
Division of Pediatric Surgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA Division of Pediatric Surgery, University of Florida College of Medicine, Gainesville, FL 32610, USA c Division of Pediatric General, Thoracic, and Neonatal Surgery, Primary Children's Medical Center, University of Utah School of Medicine, Salt Lake City, UT 84113, USA d Department of General & Thoracic Surgery, Children's Mercy Hospitals & Clinics, University of Missouri- Kansas City School of Medicine, Kansas City, MO 64110, USA e Division of Pediatric Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA 90095, USA f Division of Pediatric Surgery, Comer Children's Hospital, University of Chicago Pritzker School of Medicine, Chicago, IL 60637, USA g Division of Pediatric Surgery, C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, MI 48109, USA h Department of Pediatric Surgery, Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI 53201, USA i Department of Surgery, University of California San Diego School of Medicine, San Diego, CA 92103, USA b
Received 27 September 2010; accepted 30 September 2010
Key words: Surgical outcomes; Pediatric surgery; Overview
Abstract Outcomes research in pediatric surgery can be defined as the analysis of pediatric surgical outcomes and their predictors at different levels in the health care delivery system. The objectives of this article are to understand the differences between outcomes research and clinical trials as well as to gain familiarity with public multispecialty and specialty-specific databases. The utility of outcomes research extends to benchmarking the quality of care, refinement of management strategies, patient education, and marketing. Assessment of the integration of a new surgical technique into the health care system is best determined by examining a population-based registry, whereas comparative efficacy of surgical procedures is best assessed by randomized clinical trials. In the first part of this 2-part series, an overview and brief outline of available resources for outcomes research in pediatric surgery are reviewed. In part 2, a template is presented on how to structure and design an outcomes research question. © 2011 Elsevier Inc. All rights reserved.
☆
Presented at the 2010 Annual Meeting of the American Pediatric Surgical Association, Orlando, Fla. ⁎ Corresponding author. Tel.: +1 410 955 1983; fax: +1 410 502 5314. E-mail address: [email protected] (F. Abdullah). 1 For the 2010 APSA Outcomes Committee. 0022-3468/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2010.09.096
Outcomes research in pediatric surgery can be defined as the analysis of pediatric surgical outcomes and their predictors at different levels in the health care delivery system. This definition operates on multiple levels. Outcomes research is a relatively new field that was developed in the
222 1990s [1]. The first question that needs to be addressed is: What is the difference between outcomes research and clinical trials? Clinical trials focus on efficacy, whereas outcomes research looks at effectiveness more specifically. A clinical trial examines patient outcomes in a controlled setting, whereas outcomes research analyzes data from all patients in a generalized practice-setting environment. Clinical trials use patient subsets to delineate specific patients through inclusion criteria. Outcomes research uses all patients in the databases. Thus, in clinical trials, there is a homogenous patient population; and in outcomes research, there is a heterogeneous patient population. Clinical trials can control for patient differences by randomization; in outcomes research, one can control all patients' differences only in the analysis portion. In clinical trials, it is not critically important to track patient factors [2]. In outcomes research, it is important to track patient factors for the analysis.
F. Abdullah et al. the increasing debate on the emphasis that the National Institutes of Health has had on basic science research, which according to some researchers has had very little impact on improving clinical practice. It is not surprising that there seems to be a paradigm shift by policy makers and government in placing greater emphasis on comparative effectiveness research vs classic basic science investigations. The most striking example is the allocation by the Obama administration of only $400 million of funds to the National Institutes of Health, whereas the Agency for Healthcare Research and Quality received $300 million from the Recovery Act legislation in addition to $400 million that was placed at the discretion of the Secretary of the Department of Health and Human Services for comparativeness effectiveness research [3].
2. Outcomes research databases 1. Comparative effectiveness research vs classic basic science investigation Another important defining characteristic of outcomes research is the ability to examine factors beyond the patient level. Surgeons have classically kept their focus mostly on the patient level, with outcomes such as complications, length of hospitalization, and mortality. In contrast, outcomes research tries to analyze the health care delivery system as a whole with all of the different levels necessary for the provision of care (Fig. 1). Analysis can be performed at the level of the individual surgeon, the group, the hospital, or the geographic region. These concepts of importance of comparative effectiveness research have recently been part of
There are several outcomes research databases that are available, which contain data on children (Table 1). Five major databases will be discussed in this article. The focus of our article is the databases that are publicly available and commonly used. Databases from neonatal networks are mostly proprietary and will not be covered in this article. First among multispecialty database are administrative databases that are typically large computerized data files compiled for billing purposes. The data are gathered by billing coders and not clinicians and are mostly based on the International Classification of Diseases, Ninth Revision, coding system. The International Classification of Diseases, Ninth Revision, coding system has a separate diagnosis code as well as a separate procedure code, which
Fig. 1 Comparison of outcomes research and clinical trials with respect to their scope. Outcomes research spans from the patient level to the national level, whereas clinical trials are restricted to the patient, technique, and management level.
Outcomes research in pediatric surgery Table 1
223
Administrative and clinical databases available for pediatric surgery outcomes research
Administrative databases Database
Age
Sample size
States/facilities (y)
Issue interval Years of data
NIS
Pediatric and adult Pediatric
42 states with 1056 hospitals (2008) 38 states (2006)
Yearly
1988-2008
Every 3y
1997-2006
Pediatric and adult
8 million hospital stays each year 2-3 million hospital discharges for children 90% of all US inpatient hospital discharges
40 states (2008)
Yearly
1990-2008
Age
Sample size
States/facilities (y)
Issue interval Years of data
Hundreds of patients N1.8 million patients
25-35 US hospitals (2010) All level I-IV and other trauma centers (2009) 17 population-based cancer registries (2007) N1400 commission-accredited cancer programs (2007) All states (2010)
Yearly Yearly
2010 2002-2007
Yearly
1973-2007
Yearly
1989-2007
Yearly
1987-2010
KID SID
Clinical databases Database
NSQIP-Pediatrics Pediatric National Trauma Data Bank Pediatric and adult SEER Pediatric and adult National Cancer Data Base Pediatric and adult UNOS Pediatric and adult
N6 million cases ∼25 million records Every donor and organ transplant in the United States
allows for a higher fidelity especially for pediatric surgeons when looking at rare congenital anomalies. Clinical databases are populated through a clinician reviewer, and of these the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) is the most important [4].
3. Administrative databases Of the administrative databases, the Nationwide Inpatient Sample (NIS) is the most generalized database [5]. There are other subspecialty databases publicly available for trauma, oncology, and transplant. Fig. 2 displays the relationship between the NIS, the Kids' Inpatient Database (KID), and the
Fig. 2 The SID records all patient discharges and populates the NIS and KID. Demonstrated in the rectangle is the pediatric population of KID and NIS. A nonoverlapping NIS and KID data set can be used to create the most robust data set.
State Inpatient Database (SID). The pediatric data represent a 20% sample of the SID and the databases from all the states that have inpatient data [6]. The KID database is a weighted pediatrics sample. The NIS is about 20 years of data, which contains 5 to 8 million hospital admissions and about 1000 hospitals. The NIS incorporates both pediatrics and adult data and represents a 20% sample of US hospitals. The KID is an all-payer inpatient care database for children in the United States. It is released every 3 years (1997, 2000, 2003, 2006, and 2009). The KID contains data from 2 to 3 million hospital discharges for children. The 2006 KID contains data drawn from 38 state inpatient databases on children 20 years and younger [7]. The large sample size of KID enables analyses of both common and rare conditions such as congenital anomalies, uncommon treatments, and organ transplantation. Considering the advantages and disadvantages of these large administrative databases, the large patient numbers provides statistical power as an advantage. For example, the 2006 KID database has information from more than 38 different states, which is de-identified, but includes unique provider and hospital codes that allows for hospital level analysis and can be linked to other databases containing other non-medical information. A recent study analyzed the rates of perforated appendicitis and linked them to the area resource file, which has data about clinicians, pediatricians, and surgeons in each county [8]. Another advantage of the databases is less selection bias of the study population. There are disadvantages to these databases. They contain only inpatient data with limited clinical course information. There is no system in place to track patients once they have been discharged; however, there are some methods to get around this issue. There is also limited information regarding procedures, which may put some constraints on inquiries
224 typically of interest to surgeons. Lastly, when using databases, it is currently impossible to determine exactly when a diagnosis is given to a patient. More recent databases have attempted to have the diagnoses present on admission for a patient.
4. Clinical databases The ACS-NSQIP is the most important database with regard to pediatric surgeons. The NSQIP database is the first nationally validated adjusted outcomes program to measure and improve the quality of surgical care. It uses a prospective peer control validated database that provides 30-day riskadjusted outcomes. Although many of the hospitals had initially opted for general and vascular surgery cases only, it is designed to be multispecialty: general, vascular, gynecologic, neurosurgery, orthopedic, ENT, plastics, cardiac, thoracic, and urology [4]. The history of the adult NSQIP begins with the recognition of adverse events in the mid1980s at the Veteran Affairs (VA) hospitals. The events spurred Congress to pass a mandate to improve safety and quality at the VA hospitals. In response to that mandate, 44 VA hospitals started the National Surgical Risk Study in 1991. In 1994, NSQIP was created to include all VA hospitals, and shortly after, there was a dramatic reduction in mortality and complications. In 1999, the private sector started a pilot study with 3 hospitals and in 2001, the American College of Surgeons received a large grant from the Agency for Healthcare Research and Quality, and 14 additional medical centers participated in NSQIP. In 2004, the adult NSQIP was available to all interested hospitals and today includes more than 300 hospitals [9]. In 2005, the ACS, the American Pediatric Surgeons Association, and the University of Colorado formed a committee to design a children's NSQIP module, named NSQIP-Pediatrics. In 2008, phase 1 was implemented, where 4 hospitals involved in the pilot study tested variables and software. In 2009, phase 2 included the development of a valid model and broader implementation; hence, it was expanded to 25-35 hospitals. The pediatric NSQIP module's starting algorithm section is 35 major cases every 8 days on patients younger than 18 years. For example, on a Monday, the abstracter starts collecting cases for the next 8 days. The next cycle will begin on Tuesday, the next on Wednesday, and so forth. This allows for minimization of any bias by the day of the week. This algorithm is continually being developed and allows for collection of comprehensive data for any specific surgical procedure [10]. There is a movement within adult NSQIP and hospitals that have begun 100% capture of these procedures, which may extend to the pediatric module. There are 121 data points from most surgical specialties within the pediatric module compared to 135 in the adult NSQIP. These include demographics, hospitalization
F. Abdullah et al. characteristics, and complications with additional data points for neonates. Outcomes are assessed for 30 days after the procedure [4,10]. NSQIP-Pediatrics is a multispecialty program. Among the other specialty-specific databases, the American College of Surgeons Committee on Trauma maintains the National Trauma Data Bank, which incorporates both adult and pediatric cases. This represents the largest aggregation of US trauma data, and it is collected by hospital registrars and includes 2.7 million patients from 900 trauma centers. National Trauma Data Bank contains fairly detailed hospital outcome data [11]. The Surveillance, Epidemiology, and End Results (SEER) database, which is maintained by National Cancer Institute, is the only comprehensive source of population-based information that includes a stage of cancer, the time of diagnosis, and patient survival data. It contains adult and pediatric data from 26% of the US population by geography. The SEER program registries routinely collect data on patient demographics, primary tumor site, tumor morphology and stage at diagnosis, first course of treatment, and follow-up for vital status. The mortality data reported by SEER are provided by the National Center for Health Statistics [12]. The American College of Surgeons Committee on Cancer maintains the National Cancer Data Base. It contains adult and pediatric patients in the database and is collected from over 1400 commission-accredited cancer programs in the United States. It also contains long-term survival data until death [13]. The United Network for Organ Sharing (UNOS) database is maintained by the UNOS, which was established by Congress. Every organ donation event in the United States is included in this database since 1996, as well as long-term patient and graft survival [14].
5. Conclusion Outcomes research in pediatric surgery can be used to benchmark quality of care, compare therapeutic effectiveness, refine management strategies, provide patient education, and produce important marketing information. A population-based registry can study the applicability and integration of a new surgical technique into the health care system. Outcomes research in tandem with clinical trials allows pediatric surgeons to most completely address the efficacy and effectiveness of new surgical innovation.
Acknowledgments Author contributions: Abdullah, Chang—article concept and design; Abdullah, Chang, Ortega—drafting of the manuscript; Abdullah, Ortega, Rhee, Islam, Barnhart, St. Peter, Lee, Glynn, Teitelbaum, Arca—critical revision of the manuscript.
Outcomes research in pediatric surgery
225
References [1] Outcomes Research [Internet]. Fact Sheet. AHRQ publication no. 00-P011, March 2000. Agency for Healthcare Research and Quality, Rockville, MD. Available from: http://www.ahrq.gov/ clinic/outfact.htm. [2] National Institutes of Health and Department of Health and Human Services definition of Clinical Trials. Eunice Kennedy Shriver National Institute of Child Health & Human Development, Bethesda, MD. [Internet]. Available from: http://www.nichd.nih.gov/health/ clinicalresearch/aboutclinicaltrials.cfm. [3] Overview of the American Recovery and Reinvestment Act of 2009 (Recovery Act) [Internet]. May 2010. Agency for Healthcare Research and Quality (AHRQ), Rockville, MD. Available from: http://www. ahrq.gov/fund/cefarraover.htm. [4] Overview of the American College of Surgeons National Surgical Quality Improvement Program [Internet]. c2006 [cited 2010 Jul]. Available from: https://acsnsqip.org/main/about_overview.asp. [5] Overview of HCUP-NIS Database Utilization Project (HCUP). June Research and Quality, Rockville, hcupus.ahrq.gov/nisoverview.jsp. [6] Overview of HCUP-SID Database Utilization Project (HCUP). June Research and Quality, Rockville, hcupus.ahrq.gov/sidoverview.jsp. [7] Overview of HCUP-KID Database Utilization Project (HCUP). June
[8]
[9]
[10]
[11]
[12]
[Internet]. Healthcare Cost and 2010. Agency for Healthcare MD. Available from: www.
[13]
[Internet]. Healthcare Cost and 2010. Agency for Healthcare MD. Available from: www.
[14]
[Internet]. Healthcare Cost and 2010. Agency for Healthcare
Research and Quality, Rockville, MD. Available from: www. hcupus.ahrq.gov/kidoverview.jsp. Deng Y, Chang DC, Zhang Y, et al. Seasonal and day of the week variations of perforated appendicitis in US children. Pediatr Surg Int 2010;26(7):691-6. History of the American College of Surgeons National Surgical Quality Improvement Program [Internet]. c2006 [cited 2010 Jul 31]. Available from: http://www.acsnsqip.org/main/about_history.asp. Overview of the American College of Surgeons National Surgical Quality Improvement Program- Pediatrics [Internet]. c2009 [cited 2010 Jul 31]. Available from: http://www.pediatric.acsnsqip.org/ default.aspx. American College of Surgeons Committee on Trauma- Overview of the National Trauma Data Bank [Internet]. c1996-2010 [updated 2010 April 20; cited 2010 Jul 31]. Available from: http://www.facs.org/ trauma/ntdb/ntdbapp.html. Overview of the Surveillance, Epidemiology, and End Results Data sets [Internet]. [updated 2010 April 14; cited 2010 Jul 31]. Available from: http://seer.cancer.gov/data/. American College of Surgeons Commission on Cancer- Overview of the National Cancer Data Base [Internet]. c2002-2010 [updated 2010 June 2; cited 2010 Jul 31]. Available from: http://www.facs.org/ cancer/ncdb/index.html. U.S. Department of Health and Human Services- Health Resources and Services Administration-Organ Procurement and Transplantation Network- Overview of the United Network for Organ Sharing [Internet]. [cited 2010 Jul 31]. Available from: http://optn.transplant. hrsa.gov/data/about/.
www.elsevier.com/locate/jpedsurg
Outcomes research in pediatric surgery Part 1: overview and resources ☆ Fizan Abdullah a,⁎,1 , Gezzer Ortega a , Saleem Islam b,1 , Douglas C. Barnhart c,1 , Shawn D. St. Peter d,1 , Steven L. Lee e , Loretto Glynn f,1 , Daniel H. Teitelbaum g,1 , Marjorie J. Arca h,1 , David C. Chang i a
Division of Pediatric Surgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA Division of Pediatric Surgery, University of Florida College of Medicine, Gainesville, FL 32610, USA c Division of Pediatric General, Thoracic, and Neonatal Surgery, Primary Children's Medical Center, University of Utah School of Medicine, Salt Lake City, UT 84113, USA d Department of General & Thoracic Surgery, Children's Mercy Hospitals & Clinics, University of Missouri- Kansas City School of Medicine, Kansas City, MO 64110, USA e Division of Pediatric Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA 90095, USA f Division of Pediatric Surgery, Comer Children's Hospital, University of Chicago Pritzker School of Medicine, Chicago, IL 60637, USA g Division of Pediatric Surgery, C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, MI 48109, USA h Department of Pediatric Surgery, Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI 53201, USA i Department of Surgery, University of California San Diego School of Medicine, San Diego, CA 92103, USA b
Received 27 September 2010; accepted 30 September 2010
Key words: Surgical outcomes; Pediatric surgery; Overview
Abstract Outcomes research in pediatric surgery can be defined as the analysis of pediatric surgical outcomes and their predictors at different levels in the health care delivery system. The objectives of this article are to understand the differences between outcomes research and clinical trials as well as to gain familiarity with public multispecialty and specialty-specific databases. The utility of outcomes research extends to benchmarking the quality of care, refinement of management strategies, patient education, and marketing. Assessment of the integration of a new surgical technique into the health care system is best determined by examining a population-based registry, whereas comparative efficacy of surgical procedures is best assessed by randomized clinical trials. In the first part of this 2-part series, an overview and brief outline of available resources for outcomes research in pediatric surgery are reviewed. In part 2, a template is presented on how to structure and design an outcomes research question. © 2011 Elsevier Inc. All rights reserved.
☆
Presented at the 2010 Annual Meeting of the American Pediatric Surgical Association, Orlando, Fla. ⁎ Corresponding author. Tel.: +1 410 955 1983; fax: +1 410 502 5314. E-mail address: [email protected] (F. Abdullah). 1 For the 2010 APSA Outcomes Committee. 0022-3468/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2010.09.096
Outcomes research in pediatric surgery can be defined as the analysis of pediatric surgical outcomes and their predictors at different levels in the health care delivery system. This definition operates on multiple levels. Outcomes research is a relatively new field that was developed in the
222 1990s [1]. The first question that needs to be addressed is: What is the difference between outcomes research and clinical trials? Clinical trials focus on efficacy, whereas outcomes research looks at effectiveness more specifically. A clinical trial examines patient outcomes in a controlled setting, whereas outcomes research analyzes data from all patients in a generalized practice-setting environment. Clinical trials use patient subsets to delineate specific patients through inclusion criteria. Outcomes research uses all patients in the databases. Thus, in clinical trials, there is a homogenous patient population; and in outcomes research, there is a heterogeneous patient population. Clinical trials can control for patient differences by randomization; in outcomes research, one can control all patients' differences only in the analysis portion. In clinical trials, it is not critically important to track patient factors [2]. In outcomes research, it is important to track patient factors for the analysis.
F. Abdullah et al. the increasing debate on the emphasis that the National Institutes of Health has had on basic science research, which according to some researchers has had very little impact on improving clinical practice. It is not surprising that there seems to be a paradigm shift by policy makers and government in placing greater emphasis on comparative effectiveness research vs classic basic science investigations. The most striking example is the allocation by the Obama administration of only $400 million of funds to the National Institutes of Health, whereas the Agency for Healthcare Research and Quality received $300 million from the Recovery Act legislation in addition to $400 million that was placed at the discretion of the Secretary of the Department of Health and Human Services for comparativeness effectiveness research [3].
2. Outcomes research databases 1. Comparative effectiveness research vs classic basic science investigation Another important defining characteristic of outcomes research is the ability to examine factors beyond the patient level. Surgeons have classically kept their focus mostly on the patient level, with outcomes such as complications, length of hospitalization, and mortality. In contrast, outcomes research tries to analyze the health care delivery system as a whole with all of the different levels necessary for the provision of care (Fig. 1). Analysis can be performed at the level of the individual surgeon, the group, the hospital, or the geographic region. These concepts of importance of comparative effectiveness research have recently been part of
There are several outcomes research databases that are available, which contain data on children (Table 1). Five major databases will be discussed in this article. The focus of our article is the databases that are publicly available and commonly used. Databases from neonatal networks are mostly proprietary and will not be covered in this article. First among multispecialty database are administrative databases that are typically large computerized data files compiled for billing purposes. The data are gathered by billing coders and not clinicians and are mostly based on the International Classification of Diseases, Ninth Revision, coding system. The International Classification of Diseases, Ninth Revision, coding system has a separate diagnosis code as well as a separate procedure code, which
Fig. 1 Comparison of outcomes research and clinical trials with respect to their scope. Outcomes research spans from the patient level to the national level, whereas clinical trials are restricted to the patient, technique, and management level.
Outcomes research in pediatric surgery Table 1
223
Administrative and clinical databases available for pediatric surgery outcomes research
Administrative databases Database
Age
Sample size
States/facilities (y)
Issue interval Years of data
NIS
Pediatric and adult Pediatric
42 states with 1056 hospitals (2008) 38 states (2006)
Yearly
1988-2008
Every 3y
1997-2006
Pediatric and adult
8 million hospital stays each year 2-3 million hospital discharges for children 90% of all US inpatient hospital discharges
40 states (2008)
Yearly
1990-2008
Age
Sample size
States/facilities (y)
Issue interval Years of data
Hundreds of patients N1.8 million patients
25-35 US hospitals (2010) All level I-IV and other trauma centers (2009) 17 population-based cancer registries (2007) N1400 commission-accredited cancer programs (2007) All states (2010)
Yearly Yearly
2010 2002-2007
Yearly
1973-2007
Yearly
1989-2007
Yearly
1987-2010
KID SID
Clinical databases Database
NSQIP-Pediatrics Pediatric National Trauma Data Bank Pediatric and adult SEER Pediatric and adult National Cancer Data Base Pediatric and adult UNOS Pediatric and adult
N6 million cases ∼25 million records Every donor and organ transplant in the United States
allows for a higher fidelity especially for pediatric surgeons when looking at rare congenital anomalies. Clinical databases are populated through a clinician reviewer, and of these the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) is the most important [4].
3. Administrative databases Of the administrative databases, the Nationwide Inpatient Sample (NIS) is the most generalized database [5]. There are other subspecialty databases publicly available for trauma, oncology, and transplant. Fig. 2 displays the relationship between the NIS, the Kids' Inpatient Database (KID), and the
Fig. 2 The SID records all patient discharges and populates the NIS and KID. Demonstrated in the rectangle is the pediatric population of KID and NIS. A nonoverlapping NIS and KID data set can be used to create the most robust data set.
State Inpatient Database (SID). The pediatric data represent a 20% sample of the SID and the databases from all the states that have inpatient data [6]. The KID database is a weighted pediatrics sample. The NIS is about 20 years of data, which contains 5 to 8 million hospital admissions and about 1000 hospitals. The NIS incorporates both pediatrics and adult data and represents a 20% sample of US hospitals. The KID is an all-payer inpatient care database for children in the United States. It is released every 3 years (1997, 2000, 2003, 2006, and 2009). The KID contains data from 2 to 3 million hospital discharges for children. The 2006 KID contains data drawn from 38 state inpatient databases on children 20 years and younger [7]. The large sample size of KID enables analyses of both common and rare conditions such as congenital anomalies, uncommon treatments, and organ transplantation. Considering the advantages and disadvantages of these large administrative databases, the large patient numbers provides statistical power as an advantage. For example, the 2006 KID database has information from more than 38 different states, which is de-identified, but includes unique provider and hospital codes that allows for hospital level analysis and can be linked to other databases containing other non-medical information. A recent study analyzed the rates of perforated appendicitis and linked them to the area resource file, which has data about clinicians, pediatricians, and surgeons in each county [8]. Another advantage of the databases is less selection bias of the study population. There are disadvantages to these databases. They contain only inpatient data with limited clinical course information. There is no system in place to track patients once they have been discharged; however, there are some methods to get around this issue. There is also limited information regarding procedures, which may put some constraints on inquiries
224 typically of interest to surgeons. Lastly, when using databases, it is currently impossible to determine exactly when a diagnosis is given to a patient. More recent databases have attempted to have the diagnoses present on admission for a patient.
4. Clinical databases The ACS-NSQIP is the most important database with regard to pediatric surgeons. The NSQIP database is the first nationally validated adjusted outcomes program to measure and improve the quality of surgical care. It uses a prospective peer control validated database that provides 30-day riskadjusted outcomes. Although many of the hospitals had initially opted for general and vascular surgery cases only, it is designed to be multispecialty: general, vascular, gynecologic, neurosurgery, orthopedic, ENT, plastics, cardiac, thoracic, and urology [4]. The history of the adult NSQIP begins with the recognition of adverse events in the mid1980s at the Veteran Affairs (VA) hospitals. The events spurred Congress to pass a mandate to improve safety and quality at the VA hospitals. In response to that mandate, 44 VA hospitals started the National Surgical Risk Study in 1991. In 1994, NSQIP was created to include all VA hospitals, and shortly after, there was a dramatic reduction in mortality and complications. In 1999, the private sector started a pilot study with 3 hospitals and in 2001, the American College of Surgeons received a large grant from the Agency for Healthcare Research and Quality, and 14 additional medical centers participated in NSQIP. In 2004, the adult NSQIP was available to all interested hospitals and today includes more than 300 hospitals [9]. In 2005, the ACS, the American Pediatric Surgeons Association, and the University of Colorado formed a committee to design a children's NSQIP module, named NSQIP-Pediatrics. In 2008, phase 1 was implemented, where 4 hospitals involved in the pilot study tested variables and software. In 2009, phase 2 included the development of a valid model and broader implementation; hence, it was expanded to 25-35 hospitals. The pediatric NSQIP module's starting algorithm section is 35 major cases every 8 days on patients younger than 18 years. For example, on a Monday, the abstracter starts collecting cases for the next 8 days. The next cycle will begin on Tuesday, the next on Wednesday, and so forth. This allows for minimization of any bias by the day of the week. This algorithm is continually being developed and allows for collection of comprehensive data for any specific surgical procedure [10]. There is a movement within adult NSQIP and hospitals that have begun 100% capture of these procedures, which may extend to the pediatric module. There are 121 data points from most surgical specialties within the pediatric module compared to 135 in the adult NSQIP. These include demographics, hospitalization
F. Abdullah et al. characteristics, and complications with additional data points for neonates. Outcomes are assessed for 30 days after the procedure [4,10]. NSQIP-Pediatrics is a multispecialty program. Among the other specialty-specific databases, the American College of Surgeons Committee on Trauma maintains the National Trauma Data Bank, which incorporates both adult and pediatric cases. This represents the largest aggregation of US trauma data, and it is collected by hospital registrars and includes 2.7 million patients from 900 trauma centers. National Trauma Data Bank contains fairly detailed hospital outcome data [11]. The Surveillance, Epidemiology, and End Results (SEER) database, which is maintained by National Cancer Institute, is the only comprehensive source of population-based information that includes a stage of cancer, the time of diagnosis, and patient survival data. It contains adult and pediatric data from 26% of the US population by geography. The SEER program registries routinely collect data on patient demographics, primary tumor site, tumor morphology and stage at diagnosis, first course of treatment, and follow-up for vital status. The mortality data reported by SEER are provided by the National Center for Health Statistics [12]. The American College of Surgeons Committee on Cancer maintains the National Cancer Data Base. It contains adult and pediatric patients in the database and is collected from over 1400 commission-accredited cancer programs in the United States. It also contains long-term survival data until death [13]. The United Network for Organ Sharing (UNOS) database is maintained by the UNOS, which was established by Congress. Every organ donation event in the United States is included in this database since 1996, as well as long-term patient and graft survival [14].
5. Conclusion Outcomes research in pediatric surgery can be used to benchmark quality of care, compare therapeutic effectiveness, refine management strategies, provide patient education, and produce important marketing information. A population-based registry can study the applicability and integration of a new surgical technique into the health care system. Outcomes research in tandem with clinical trials allows pediatric surgeons to most completely address the efficacy and effectiveness of new surgical innovation.
Acknowledgments Author contributions: Abdullah, Chang—article concept and design; Abdullah, Chang, Ortega—drafting of the manuscript; Abdullah, Ortega, Rhee, Islam, Barnhart, St. Peter, Lee, Glynn, Teitelbaum, Arca—critical revision of the manuscript.
Outcomes research in pediatric surgery
225
References [1] Outcomes Research [Internet]. Fact Sheet. AHRQ publication no. 00-P011, March 2000. Agency for Healthcare Research and Quality, Rockville, MD. Available from: http://www.ahrq.gov/ clinic/outfact.htm. [2] National Institutes of Health and Department of Health and Human Services definition of Clinical Trials. Eunice Kennedy Shriver National Institute of Child Health & Human Development, Bethesda, MD. [Internet]. Available from: http://www.nichd.nih.gov/health/ clinicalresearch/aboutclinicaltrials.cfm. [3] Overview of the American Recovery and Reinvestment Act of 2009 (Recovery Act) [Internet]. May 2010. Agency for Healthcare Research and Quality (AHRQ), Rockville, MD. Available from: http://www. ahrq.gov/fund/cefarraover.htm. [4] Overview of the American College of Surgeons National Surgical Quality Improvement Program [Internet]. c2006 [cited 2010 Jul]. Available from: https://acsnsqip.org/main/about_overview.asp. [5] Overview of HCUP-NIS Database Utilization Project (HCUP). June Research and Quality, Rockville, hcupus.ahrq.gov/nisoverview.jsp. [6] Overview of HCUP-SID Database Utilization Project (HCUP). June Research and Quality, Rockville, hcupus.ahrq.gov/sidoverview.jsp. [7] Overview of HCUP-KID Database Utilization Project (HCUP). June
[8]
[9]
[10]
[11]
[12]
[Internet]. Healthcare Cost and 2010. Agency for Healthcare MD. Available from: www.
[13]
[Internet]. Healthcare Cost and 2010. Agency for Healthcare MD. Available from: www.
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