Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-22T19:27:40.776Z Has data issue: false hasContentIssue false
  • English
  • Français

Introduction – Databases and the assessment of complications associated with the treatment of patients with congenital cardiac disease

Part of: The International Society for Nomenclature of Paediatric and Congenital Heart Disease (ISNPCHD)

Published online by Cambridge University Press:  01 December 2008

Jeffrey P. Jacobs
Jeffrey P. Jacobs*
Affiliation:
The Congenital Heart Institute of Florida (CHIF), Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital and Children’s Hospital of Tampa, University of South Florida College of Medicine, Cardiac Surgical Associates (CSA), Saint Petersburg and Tampa, Florida, United States of America
*
Correspondence to: Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP, Cardiovascular and Thoracic Surgeon, Surgical Director of Heart Transplantation and ECMO, The Congenital Heart Institute of Florida (CHIF), Children’s Hospital and Children’s Hospital of Tampa, Clinical Associate Professor, University of South Florida (USF), Cardiac Surgical Associates (CSA), 625 Sixth Avenue South, Suite 475, Saint Petersburg, Florida 33701, United States of America. Office Phone: (727) 822–6666; Office Fax: (727) 821- 5994; Cell Phone: (727) 235–3100; E-mail: [email protected]; Web Page: http://www.heartsurgery-csa.com/; Web Page: http://www.CHIF.us/
Get access Rights & Permissions [Opens in a new window]

Abstract

The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease was established in 2005 with the goal of providing the infrastructure, spanning geographical and subspecialty boundaries, for collaboration between health care professionals interested in the analysis of outcomes of treatments provided to patients with congenital cardiac disease, with the ultimate aim of improvement in the quality of care provided to these patients. The purpose of these collaborative efforts is to promote the highest quality comprehensive cardiac care to all patients with congenital heart disease, from the fetus to the adult, regardless of the patient’s economic means, with an emphasis on excellence in teaching, research and community service. This manuscript provides the Introduction to the 2008 Supplement to Cardiology in the Young titled: “Databases and The Assessment of Complications associated with the Treatment of Patients with Congenital Cardiac Disease”. This Supplement was prepared by The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.

The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Complication”: “A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval.”

The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Adverse Event”: “An adverse event is a complication that is associated with a healthcare intervention and is associated with suboptimal outcome. Adverse events represent a subset of complications. Not all medical errors result in an adverse event; the administration of an incorrect dose of a medication is a medical error, but it does not always result in an adverse event. Similarly, not all adverse events are the result of medical error. A child may develop pneumonia after an atrial septal defect repair despite intra- and peri-operative management that is free of error. Complications of the underlying disease state, which are not related to a medical intervention, are not adverse events. For example, a patient who presents for medical care with metastatic lung cancer has already developed a complication (Metastatic spread) of the primary lung cancer without any healthcare intervention. Furthermore, complications not associated with suboptimal outcome or harm are not adverse events and are known as no harm events. The patient who receives an incorrect dose of a medication without harm has experienced a no harm event, but not an adverse event.”

Based on the above definitions, it is apparent that The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease has taken an inclusive approach to defining the universe of complications. Complications may or may not be associated with healthcare intervention and may or may not be associated with suboptimal outcome. Meanwhile, adverse events must be associated with healthcare intervention and must be associated with suboptimal outcome.

Keywords

Congenital heart diseaseoutcomescomplexitypatient safetycomplicationssurgical outcomesregistrydatabasepatient safetycardiac surgeryresults of treatment
Type
Introduction
Information
Cardiology in the Young , Volume 18 , Issue S2: Databases and the assessment of complications associated with the treatment of patients with congenital cardiac disease , December 2008 , pp. 1 - 37
Copyright
Copyright © Cambridge University Press 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Kohn, LT, Corrigan, JM, Donaldson, M (eds). Committee on Quality of Health Care in America, Institute of Medicine (IOM) Report – To Err Is Human: Building a Safer Health System. National Academy of Sciences, Washington, DC, 2000. (Free Executive Summary). [http://www.nap.edu/catalog/9728.html], accessed October 11, 2007.Google Scholar
2.Brennan, TA, Leape, LL, Laird, NM, et al. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: 370–376; See also: Leape LL, Brennan TA, Laird NM, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377–384. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care forthcoming Spring 2000.CrossRefGoogle ScholarPubMed
3.Thomas, EJ, Studdert, DM, Newhouse, JP, et al. Costs of Medical Injuries in Utah and Colorado. Inquiry 1999; 36: 255–264; See also: Leape, et al., 1991; Brennan, et al., 1991.Google ScholarPubMed
4. American Hospital Association. Hospital Statistics. Chicago. 1999.Google Scholar
5.Centers for Disease Control and Prevention (National Center for Health Statistics). Deaths: Final Data for 1997. National Vital Statistics Reports 1999; 47: 27.Google Scholar
6.Centers for Disease Control and Prevention (National Center for Health Statistics). Births and Deaths: Preliminary Data for 1998. National Vital Statistics Reports 1999; 47: 6.Google Scholar
7. [http://www.qualityforum.org/], accessed October 12, 2008.Google Scholar
8.Jacobs, JP. Caring for Patients with Congenital Cardiac Disease – Introduction to Part 6 of the Supplement. Cardiol Young 2005; 15 (Suppl 1): 159–160.CrossRefGoogle Scholar
9.Cohen, M, Jacobs, JP, Quintessenza, JA, et al. Mentorship, learning curves and balance. Cardiol Young 2007; 17 (Suppl 2): 164–174; doi: 10.1017/S1047951107001266.CrossRefGoogle ScholarPubMed
10.Bonchek, LI, Harley, DP, Wilbur, RH, et al. The STS future planning conference for adult cardiac surgery. Ann Thorac Surg 2003; 76: 2156–2166.CrossRefGoogle ScholarPubMed
11.Mayer, JE . Threats to the Medical Profession by the American Medicare System. Presented as a Visiting Professor at the Ninth Annual Anthony RC Dobell Day in Congenital Cardiac Surgery, Montreal Children’s Hospital and McGill University, Montreal, Canada, Monday, December 4, 2006.Google Scholar
12.The Reserves of Life. St. Mary’s Hosp Gaz 1907; 13: 95–98.Google Scholar
13. [http://www.acponline.org/college/pressroom/osler_feat.htm], accessed October 11, 2007.Google Scholar
14.Jacobs, JP, Franklin, RCG, Jacobs, ML, et al. Classification of the functionally univentricular heart: Unity from mapped codes. Cardiol Young 2006; 16 (Suppl 1): 9–21.CrossRefGoogle ScholarPubMed
15.Tchervenkov, CI, Jacobs, JP, Weinberg, PM, et al. The nomenclature, definition and classification of hypoplastic left heart syndrome. Cardiol Young 2006; 16: 339–368.CrossRefGoogle ScholarPubMed
16.Jacobs, JP, Franklin, RCG, Wilkinson, JL, et al. The nomenclature, definition and classification of discordant atrioventricular connections. Cardiol Young 2006; 16 (Suppl 3): 72–84.CrossRefGoogle ScholarPubMed
17.Jacobs, JP, Anderson, RH, Weinberg, P, et al. The nomenclature, definition and classification of cardiac structures in the setting of heterotaxy. Cardiol Young 2007; 17 (Suppl 2): 1–28; doi: 10.1017/S1047951107001138, September 2007.Google ScholarPubMed
18.Jacobs, JP, Mavroudis, C, Jacobs, ML, et al. Lessons learned from the data analysis of the Second Harvest (1998–2001) of The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. Eur J Cardiothorac Surg 2004; 26: 18–37.CrossRefGoogle Scholar
19.Jacobs, JP, Lacour-Gayet, FG, Jacobs, ML, et al. Initial application in the STS congenital database of complexity adjustment to evaluate surgical case mix and results. Ann Thorac Surg 2005; 79: 1635–1649.CrossRefGoogle ScholarPubMed
20.Jacobs, JP, Jacobs, ML, Maruszewski, B, et al. Current status of the European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital Heart Surgery Database. Ann Thorac Surg 2005; 80: 2278–1183; discussion 2283–2284.CrossRefGoogle Scholar
21.Jacobs, JP, Mavroudis, C, Jacobs, ML, et al. What is operative mortality? Defining death in a surgical registry database: a report of the STS Congenital Database Taskforce and the Joint EACTS-STS Congenital Database Committee. Ann Thorac Surg 2006; 81: 1937–1941.CrossRefGoogle Scholar
22.Jacobs, JP, Jacobs, ML, Mavroudis, C, et al. What is operative morbidity? Defining complications in a surgical registry database: a report from the STS Congenital Database Task Force and the Joint EACTS-STS Congenital Database Committee. Ann Thorac Surg 2007; 84: 1416–1421.CrossRefGoogle Scholar
23.Jacobs, JP, Mavroudis, C, Jacobs, ML, et al. Nomenclature and databases – the past, the present, and the future: a primer for the congenital heart surgeon. Pediatr Cardiol 2007; 28: 105–115; Epub 2007 May 4, May 2007.CrossRefGoogle ScholarPubMed
24.Jacobs, JP, Wernovsky, G, Elliott, MJ. Analysis of outcomes for congenital cardiac disease: Can we do better? Cardiol Young 2007; 17 (Suppl 2): 145–158; doi: 10.1017/S1047951107001278, September 2007.CrossRefGoogle ScholarPubMed
25.Jacobs, JP, Haan, CK, Edwards, FH, et al. The rationale for incorporation of HIPAA compliant unique patient, surgeon, and hospital identifier fields in the STS Database. Ann Thorac Surg 2008; 86: 695–698; doi:10.1016/j.athoracsur.2008.04.075. September, 2008.CrossRefGoogle ScholarPubMed