Notice of Concern

Concern has been raised regarding the scientific integrity of several articles published in the Journal of the American College of Cardiology under the leadership of or collaboration of Dr. Don Poldermans. This concern has resulted in an extensive investigation both of papers published in JACC and other journals by an Investigation Committee of Erasmus Medical Center in Rotterdam, Netherlands. The Editors of JACC (Jeroen Bax recused himself) have carefully read the report of the Investigative Committee, http://www.erasmusmc.nl/5663/135857/3675250/3706798/Integrity_report_2012-10.pdf?lang=en&lang=en, and have concluded that it was performed with rigor, accurately, and objectively. Therefore, we wish to report our concern regarding the scientific integrity of these articles based upon the conclusions of the Investigative Committee of Erasmus Medical Center.Poldermans D, Bax JJ, Schouten O, Neskovic AN, Paelinck B, Rocci G, van Dortmont L, Durazzo A, van de Ven L, van Sambeek M, Kertai MD, Boersma E, for the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo Study Group. Should major vascular surgery be delayed because of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate control? J Am Coll Cardiol 2006;48:964–9.

In regard to this study the Investigative Committee was unable to confirm with certainty that the process of written informed consent was performed appropriately. In regard to the statement in the publication that patients were screened for several cardiac risk factors to classify them into three distinct categories, the Committee established several inconsistencies between source documentation and the patients risk factors as recorded on the Case Report Forms. The research protocol specified that study outcomes had to be assessed by an Independent Committee consisting of two cardiologists. The Investigative Committee concluded that no formalized arrangement with two independent cardiologists had been made and that an Adverse Events Committee did not exist. In practice, clinical data were collected by a junior researcher. Finally, the Committee noted an unreliable working procedure for collection of scientific data. The Case Report Form was not consistently used as the universal master document for data collection. As a result the Committee observed inconsistencies between the Case Report Form and the research data base.

In spite of the irregularities mentioned above, the Committee did not find evidence for any manipulation of the research results by the researchers in the sense of deliberate steering of results into a particular direction. Although the Committee found several irregularities in the execution of the study, the Committee had no evidence that the research conclusions as published in the above mentioned article are wrong. In view of the above findings, and since the manuscript was the report of a multi-center trial, it is impossible for the Editors of JACC to determine the effect of this breach of scientific integrity upon the overall conclusions of the manuscript.Biagini E, Elhendy A, Bax JJ, Rizzello V, Schinkel AF, van Domburg RT, Kertai MD, Krenning BJ, Bountioukos M, Rapezzi c, Branzi A, Simoons ML, Poldermans D. Seven-year follow-up after dobutamine stress echocardiography: impact of gender on prognosis. J Am Coll Cardiol 2005;45:93–7.The Investigative Committee indicated that there is doubt about the validity of the causes of death recorded in the data base. The Committee found that the source documentation in relation to the reported causes of death is missing. However, since the research was not subject to the Medical Research involving Human Subjects Act HS&A and was performed about ten years ago, the Committee categorizes the lack of source documentation as unfortunate but not as negligent. Because of these circumstances, the Committee was not able to investigate the validity of the reported causes of death, or deliver any judgment on the results and conclusions in the publications mentioned above. Again, the Editors of JACC could not determine how these facts influenced the conclusions of the manuscript.Poldermans D, Schouten O, Vidakovic R, Bax JJ, Thomson IR, Hoeks E, Feringa HHH, Dunkelgrin M, de Jaegere P, Maat a, van Sambeek RHM, Kertai MD, Boersma E, for the DECREASE Study Group. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE V pilot study. J Am Coll Cardiol 2007;49:1763–9.The Investigative Committee found that the informed consent procedures was applied negligently. The Committee also considers the failure to preserve case report forms to be negligent, and the way in which data collection was done to be both negligent and scientifically incorrect. The Committee considers the way in which outcomes were determined to be scientifically incorrect. On the basis of available information, the Investigative Committee considered that it is not possible, in relation to the DECREASE V Study, to vouch for the reliability of the findings in the publications and for the validity of the conclusions. The conclusions of the Committee regarding the DECREASE II Study also applied to the DECREASE V Study. As was true for prior publications, the JACC Editors could not determine with certainty that the findings of the study were erroneous.

Since it is not possible for the Editors of JACC to determine with certainty that the findings in the above articles were erroneous, we have elected not to retract these manuscripts. However, given the uncertainty regarding the accuracy of the data, and the inability to validate the collection of data, readers should be cautioned in the application of the findings of these manuscripts to clinical practice.