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.