Good afternoon, I'm Dr. Norma Smalls-Monte, trauma surgeon and intensivist at Howard University Hospital in Washington, D.C. I have no disclosures. Our learning objectives for this talk will be to identify several widely disseminated yet significantly flawed research papers about COVID-19 viral disease, which were published between 2020 and 2022 and have subsequently been retracted. We will review several factors which led to such an unprecedented number of flawed COVID-19 virus publications during this time period, and we'll also review some of the basic or review or reemphasize some of the basic principles of sound medical research and steps which we may take to prevent this from recurring in the future. So it is well known that modern medical decision-making depends upon high-quality research to inform evidence-based practice. From 2020 to 2022, the greatly enhanced publication rate on research about COVID-19 and SARS resulted in an unprecedented rate of publication retractions. Efforts were needed to ameliorate the flaws that occurred. Since 2020, over 270,000 research articles have been published on COVID and SARS. Publishers pushed to publish relevant and pertinent scientific research on COVID-19 and SARS, which led to less scrutiny and inadequate vetting of the research. The peer review process was often delayed or at times completely bypassed for faster publication. And as a result, an unprecedented number of research articles in clinical studies have been retracted. It was up to 285 as of last week. I'm going to go over four significant research publications that will aptly demonstrate the problem that we were facing. In May 2020, the Lancet put out a publication claiming that hydroxychloroquine led to an increased risk of mortality and it was associated with cardiac arrhythmias at a time when this drug was largely untested. This paper was retracted after two weeks, but by then the World Health Organization had already acted based on this study's erroneous findings. And in May 2020, the New England Journal of Medicine put out a publication claiming a link between COVID-19 infection and an increased mortality risk for those with heart disease. However, the study found no elevated risk of death from certain heart medications which were previously thought to be harmful. This paper was also retracted after five weeks. In April of 2020, Social Science Research Network put out a communication claiming a link between COVID-19 deaths and low vitamin D levels. These preprint findings were subsequently published in the British Medical Journal and the British Heart Foundation. The paper was removed after two months and it was found that both the data and the authors were fraudulent. And in March 2021, Toxicology Reports put out a study, published a study that involved only 32 patients. The patients were randomized to either standard of care or standard of care plus ivermectin. The study found that standard of care treatment together with ivermectin did not result in any serious adverse events and all patients exhibited a reduction in SARS viral load within seven days. However, it also stated that those who received ivermectin had a more consistent decrease as compared to those randomized to standard of care alone and this was characterized to reaching two consecutive negative PCR tests. This article as well as a number of other similar ivermectin studies was retracted and the publishers stated that it was due to clear evidence that the findings were unreliable. So what have we learned about why the retractions occurred in such high numbers and what were the main reasons for the retractions? Although it was important to publish information about the rapidly expanding pandemic which carried a high risk for mortality, in doing so, the publishing processes were often compromised as relates to peer review and statistical validation. A high number of high profile retracted publications were based on data from the Surgisphere database which fraudulently claimed to have collected data from the electronic health records of nearly 100,000 COVID-19 patients across 671 hospitals on six continents. The fraudulent information drove international health policy and brought major clinical trials to a halt within the span of a few weeks. Now we know that the process of retraction can be lengthy and often by the time the paper has been retracted, other authors have used the flawed data as a basis for their conclusions, thus compounding the problem. One author identified 212 retractions among 27,000 COVID-19 publications and he found that the retracted studies had been cited elsewhere 2,697 times which is approximately seven times per paper. The justifications given for retraction of journal articles in general. In general, not just COVID-19 publications are many and some of them are compromised peer review, manipulated peer review, plagiarism, data integrity, analysis error, duplication, fabrication and failure to obtain IRB approval. And the journals which retracted the COVID-19 publications were of significant stature and included Elsevier, Springer, Med Archive and Bio Archive, Taylor and Francis, Curious, Wiley and British Medical Journal Publishing. So some of the general principles of sound medical research we're just going to briefly mention now. We just have to keep them in line so we won't run into this type of problem again. And some of the characteristics of acceptable medical research include it should be replicable, reproducible and transparent. There should be a sound research question often using the finer or PICO methods. It should follow systematic appropriate research methodology. Should acknowledge previous research on the topic. It should utilize relevant empirical data and proper data analysis. It should be guided by logical processes of induction and deduction. Should have external validity and it should acknowledge limitations and provide suggestions for future research. On the other spectrum, some of the top mistakes made in medical research in general are failure to construct a sound research question that is clinically or scientifically relevant and can be practically investigated. Failure to review existing literature prior to initiating the study, thus lessening the potential for research duplication and inclusion of retracted studies. Failure to calculate and report the required sample size, thus lessening the potential for type 1 and type 2 errors. Failure to consider the impact of intention to treat or protocol analyses. Failure to adequately define variables and data. Not differentiating between allocation concealment and blinding, the goals of which are both to minimize bias and to use the highest level of blinding possible. Failure to use appropriate descriptive statistics and drawing inappropriate conclusions from non-inferiority and superiority studies. So moving forward, what are the measures that we can take to avoid these mistakes in the future? Authors, journal editors and review teams must keep in mind that swiftly published but erroneous data is not helpful for the medical community in this ongoing battle with COVID-19. Correct, meticulous and unbiased information passed through rigorous critical appraisal methods are imperative. And finally, following research and publishing guidelines along with the use of established oversight processes from organizations such as the Committee on Publication and Ethics, the National Policy on Ethics, the European Association of Science Editors and the Society for Scientific Values warrant consideration. Thank you.

COVID-19

flawed research papers

retracted publications

peer review

fraudulent data