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Eur J Cardiothorac Surg 2005;28:405-406
© 2005 Elsevier Science NL
Original articles |
Chief, Section of Cardiothoracic Surgery, St Christopher's Hospital for Children, Professor of Cardiothoracic Surgery, Drexel University College of Medicine, Philadelphia, PA, USA
* Corresponding author. Tel: +1 215 427 5109; fax +1 215 427 3860. (Email: marshall.jacobs{at}tenethealth.com).
With a history that dates back to the first successful ligation of a patent ductus arteriosus by Dr Robert Gross in 1938, the field of congenital heart surgery has a life history that is stretching into is seventh decade. Yet the appearance of multi-institutional national or multi-national regional registry databases to record and evaluate outcomes from congenital heart surgery was really a phenomenon of the decade of the nineties. And as such, these essential tools for quality assessment and quality improvement are in fact barely beyond their infancy. Unlike adult cardiac surgery for acquired heart disease, the challenge related to data management for congenital heart surgery is of greater magnitude, because the anatomic diagnoses and the palliative and reparative operative procedures number not in the dozens, but in the hundreds. Nonetheless, the international community of congenital hearts surgeons recognized early on the importance of physician-led outcomes analysis in our rapidly developing field. This recognition stemmed not only from altruism and the genuine desire to advance and improve patient care, but also in response to the dramatic and far-reaching consequences of periodic publications in the non-scientific press of non-validated, non-verified, non-stratified and sometimes frankly inaccurate outcome statistics. As stated by Dr William Williams at the 2004 meeting of the Society of Thoracic Surgeons, "Outcomes for cardiac surgery are closely scrutinized and expectations are very high. It is timely that we as a profession develop a report card for congenital heart surgery. The report card must be timely, freely available, and fairly represent the case mix....of the wide spectrum of congenital heart disease that we treat" [1].
During the early portion of the decade of the nineties, both the European congenital heart surgery community (ECHSF and EACTS) and the Society of Thoracic Surgeons in North America created congenital heart surgery databases. A number of lessons were learned from these early experiences. Four primary requirements emerged as essential features of a successful international multi-institutional congenital heart surgery database:
In 1998, the International Congenital Heart Surgery Nomenclature and Database Project was established jointly by the STS and the EACTS. This project addressed the first two items in the list above, producing a common nomenclature and common uniform core dataset which were adopted by both organizations[2]. The EACTS-STS Aristotle Committee [3] was created to address the third item on the list. And together, and in parallel, the directors of the EACTS and STS Congenital Heart Surgery Databases have endeavored to deal with the fourth essential requirement, a mechanism to assure and verify data completeness and accuracy. So far both groups have proceded in similar fashion, adhering at the outset to the idea that the database software should be designed in such a way as to ensure internal validation of the data (consistency of dates, ages, etc.), and the idea that data verification is essential to reliability of the database and is best accomplished by Source Data Verification. In this issue of the Journal, Maruszewski and his EACTS colleagues report on the process of Source Data Verification at five of their largest volume participating centers. This encompassed approximately one third of the cases harvested from all participating centers for the year 2003. The site visits took place during one month of the calendar year 2004. As recommended by the World Health Organization, validation was by means of comparison of the data entered into the database to original records at their site of origin. While certain demographic and operative details were evaluated, the principle goal was the assessment of three outcome fields: mortality at thirty days after operation, length of hospital stay, and duration of positive pressure ventilator support. Mortality is easily enough understood, though the importance and appropriateness of thirty day mortality (vs. discharge mortality or absolute mortality) is the subject of ongoing debate (the STS congenital heart surgery database reports currently reflect mortality status [alive or dead] at hospital discharge, since this data field is more often completed than is thirty day mortality). The other two, length of stay and duration of ventilation, are taken as important but rather imprecise surrogates for overall morbidity.
Data had been entered into the database on all but 2 of 1705 patients. Duration of ventilator support was not available in three of five centers. After a Herculean effort at on-site verification, the investigators report "no statistically significant differences found between verified and non verified data ....as far as age, aortic cross-clamp time, circulatory arrest, cardiopulmonary bypass time, length of stay and body weight." Seemingly, the patient demographics and the operative variables were entered with considerable precision. They also reported "no statistically significant differences between pre and post verification mortalities ...nevertheless 7 deaths were missed out of 68 deaths found after verification (10.27%)." Should this finding be taken as disturbing? Surely it is important. It has been previously shown that patients not included in a medical audit generally have a worse outcome than those included [4]. A cynical interpretation would be that the participating centers knowingly failed to report some of the thirty day mortalities, but this is unlikely given their voluntary and enthusiastic participation in the site visit data verification project. The importance and inherent difficulty in verifying the accuracy of such data is demonstrated in a recent report from the United Kingdom Central Cardiac Audit Database (UK CCAD). The UK CCAD analyzed 3666 surgical procedures and 1828 therapeutic catheterizations from 2000 and 2001. Thirty day mortality was identified both by volunteered life status from the hospital databases and by independently validated life status through the Office for National Statistics. Central tracking of mortality identified 469 deaths, 194 occurring within 30 days. Forty-two of the 194 deaths within 30 days (21.6% of the thirty day mortality) were detected by central tracking but not by volunteered data. In other words, in that instance, hospital based databases had under reported thirty day mortality by more than twenty percent even though the hospitals were aware that the data would be independently verified [5].
Where then does this leave us? Certainly the hypothesis of Maruszewski et al that our "report card" should reflect verified data is unassailable. The reader is left reflecting on the magnitude of the task and wondering if the authors, in their modesty, did not understate the labor-intense and resource-demanding nature of the on-site data verification process. And what about the as yet unanswered questions? Must we verify all of the data, or can an audit of a "statistically representative" biopsy of the data be taken as sufficient? How does one adequately and practically define mortality? Is it sufficient to know status at thirty days, or at discharge? Once the process of verification has begun, how often must each center be re-visited for verification to be current and complete? And ultimately, who shall bear the cost of this complex process that takes us to the new frontier where complete and verifiably accurate outcome data is available to guide our efforts at quality assessment and quality improvement? Certainly the authors deserve our gratitude and congratulations for the pioneering effort that points the way to the future.
References
This article has been cited by other articles:
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  J. P. Jacobs, M. L. Jacobs, C. Mavroudis, B. Maruszewski, C. I. Tchervenkov, F. G. Lacour-Gayet, D. R. Clarke, T. Yeh Jr, H. L. Walters III, H. Kurosawa, et al. What is Operative Morbidity? Defining Complications in a Surgical Registry Database Ann. Thorac. Surg., October 1, 2007; 84(4): 1416 - 1421. [Full Text] [PDF]
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 M. Neuhauser, N. Lehmann, M. Nonnemacher, and J. Stausberg An attempt at data verification in the EACTS Congenital Database: data before and after verification differ significantly. Eur. J. Cardiothorac. Surg., October 1, 2006; 30(4): 691 - 691. [Full Text] [PDF]
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