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• W2137349462 abstract "Napoleon’s march on Moscow commenced on June 23, 1812, as the Grande Armée of 691,500 men, the largest army assembled in European history, crossed the Neman River. Attrition during its advance and ignominious winter retreat, to 22,000 men on December 14, 1812, when it recrossed the river, was depicted by Charles Joseph Minard in what many consider the best statistical graphic ever produced (Figure 1). Less spectacular, but terribly informative, was the depiction along similar lines of patients screened for entry into the Coronary Artery Surgery Study (CASS) at 11 randomizing sites, dwindling from 16,626 to 780 randomized patients (Figure 2).1Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery. Survival data.Circulation. 1983; 68: 939-950Crossref PubMed Scopus (989) Google ScholarSee related articles on pages 233, 241, 243, 245, 247, and 249.Figure 2Depiction of the Coronary Artery Surgery Study population, from initial screening of 16,626 patients to a final randomized group of 780. Adapted from Figure 1 from the report of the Coronary Artery Surgery Study.1Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery. Survival data.Circulation. 1983; 68: 939-950Crossref PubMed Scopus (989) Google ScholarView Large Image Figure ViewerDownload (PPT) See related articles on pages 233, 241, 243, 245, 247, and 249. In the mid-1990s, an international group of journal editors, statisticians, and clinical trialists sought to improve the quality of reporting randomized controlled trials (RCTs). They devised the CONSORT (Consolidated Standards of Reporting Trials) statement, checklist, and flowchart1Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery. Survival data.Circulation. 1983; 68: 939-950Crossref PubMed Scopus (989) Google Scholar, 2Moher D. Schulz K.F. Altman D. The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials.JAMA. 2001; 285: 1987-1991Crossref PubMed Scopus (2023) Google Scholar for reporting RCTs that had at its core a complete accounting for cases, from screening through final analysis. Although not as dramatic and artistic as either the Minard or CASS trial graph, the CASS trial CONSORT flowchart is highly informative and even reveals holes in the report (Figure 3). Biomedical journals, including the Journal of Thoracic and Cardiovascular Surgery, were asked to adopt CONSORT and to require authors to comply with its reporting standards, not just follow a set of recommendations, guidelines, or suggestions. Not wishing to be prescriptive, this journal included CONSORT as recommendations in “Instructions to Statisticians” (then a separate document from “Instructions to Authors”). This separate set of instructions, however, was subsequently dispensed with, and with it, CONSORT. Tiruvoipati and colleagues3Tiruvoipati R. Balasubramanian S.P. Atturu G. Peek G.J. Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery the way forward.J Thorac Cardiovasc Surg. 2006; 132: 233-240Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar in this issue have taken cardiothoracic journals to task for publishing RCTs that do not comply with CONSORT and for not officially subscribing to it. They document why suboptimal reporting is a handicap both to full understanding of a trial and to its future use in high-quality meta-analyses. By implication, they also believe that not using the CONSORT flowchart and checklist from the very outset of a trial can decrease its quality. We challenged the authors to use data they had gathered to look at a compliance-study quality correlation, but they declined the opportunity. After all, we reasoned, if quality of the trial is not improved by CONSORT, why force authors to go through a standardized reporting process only for receiving a higher score on someone else’s meta-analysis quality scale? However, careful study of the CONSORT documents will convince anyone involved in either RCTs or observational clinical research that the flowchart and checklist capture exactly the information that is needed for good science. Indeed, if used from the outset in planning a study, it keeps ever before the investigator things that might otherwise be forgotten or be reinvented study by study. Thus, we view CONSORT as an excellent starting point for a well-conceived clinical study of any kind rather then just another hoop to jump through to get an article into publication. Thus, the editors of this journal have reviewed CONSORT and recommended that the following statement be added to “Instructions for Authors”: Manuscripts reporting the results of randomized controlled trials (RCTs) should include the CONSORT flow diagram showing the progress of patients throughout the trial.4Available at http://www.consort-statement.orgGoogle Scholar The CONSORT checklist also should be completed and submitted with the manuscript. When we received the manuscript from Tiruvoipati and colleagues,3Tiruvoipati R. Balasubramanian S.P. Atturu G. Peek G.J. Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery the way forward.J Thorac Cardiovasc Surg. 2006; 132: 233-240Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar we also believed that it could catalyze a useful and serious discussion of some important issues that RCTs raise in surgery. Our bias is that there are not enough cardiothoracic surgical RCTs. However, we recognize that there are limited funding sources for such studies, unlike drug trials. Furthermore, surgery is not a uniform standardized dose like a pill but is always confounded by the skill of the surgeon. Randomized trials also go against one of the fundamental things surgeons do: select an appropriate operation for the appropriate patient. We call this “indication” not “bias.” RCTs seek to erase selection “bias.” To air these and other RCT issues of interest to surgeons, we have asked the reviewers of the article by Tiruvoipati and colleagues3Tiruvoipati R. Balasubramanian S.P. Atturu G. Peek G.J. Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery the way forward.J Thorac Cardiovasc Surg. 2006; 132: 233-240Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar to write brief commentaries dealing either with issues raised by the article or with RCTs in general. These individuals are a diverse group: a cardiologist and contributing editor of the Journal of the American Medical Association; a surgeon–mathematician and head of the Coordinating Center for the National Emphysema Treatment Trial, who has written one of the definitive texts on clinical trials5Piantadosi S. Clinical trials. John Wiley & Sons, New York1997Google Scholar; a cardiac surgeon–ethicist; and a neurosurgeon who has led many important surgical RCTs and is the founding editor in chief of the Annals of Surgical Oncology and CEO of the American Society of Clinical Oncology. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forwardThe Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewTo evaluate the quality of reporting of randomized controlled trials in cardiothoracic surgery, to identify factors associated with good reporting quality, and to assess the awareness of the Consolidated Standards for Reporting of Trials statement and ascertain the views of authors reporting randomized controlled trials on the difficulties in conducting randomized controlled trials and the possible ways to further improve the reporting quality of randomized controlled trials in cardiothoracic surgery. Full-Text PDF Randomized clinical trials in surgery: Why do we need them?The Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewRandomized clinical trials (RCTs) are a fundamental tool for surgical investigators to validate new therapies, but they are still used sparingly, and the results are reported in an inconsistent format. This conclusion is highlighted by the provocative article by Tiruvoipati and colleagues,1 who report in this issue on the use of the CONSORT statement, a checklist and flowchart used in reporting results of RCTs, in the cardiothoracic surgery literature. This important statement is endorsed by many medical journals but not by most surgical journals. Full-Text PDF Randomized controlled trials in surgery: Comic opera no more?The Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewThe ultimate goal of clinical research is to provide the best information to optimally guide the management of a given patient with a particular problem confronting us. Specifically, surgeons might wish to compare medications, surgical techniques, or combinations thereof for a given condition. Randomized controlled trials (RCTs) help to circumvent several major obstacles hindering investigations of this nature. Through randomization, selection bias is theoretically removed, and confounding factors are distributed evenly among groups to mitigate their potential influences. Full-Text PDF Reports of clinical trials: Ethical aspectsThe Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewTiruvoipati and colleagues1 have shown us glaring deficiencies in the reporting of randomized controlled trials (RCTs) in the cardiothoracic surgery (CTS) literature. The CONSORT statement, a checklist and flowchart used in writing reports of RCTs, is a tool that can be used to improve RCT reports; it is endorsed by most major medical journals but by none of the major cardiothoracic journals. Why is this? One reason might be that RCTs are not as applicable to surgical as to medical disciplines. Indeed, the authors observe that RCTs are only half as prevalent in our journals as they are in general medical journals, and therefore CTS journal editors might be less inclined to pay attention to quality of reporting of low-incidence articles. Full-Text PDF Improving the quality of clinical trials in surgeryThe Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewThe current work by Tiruvoipati and colleagues1 measures substantive deficiencies in the reporting of randomized trials in the surgical literature. Among other things, the authors of that report indicate that lack of awareness of the CONSORT guidelines2 contributes to the deficiencies they observed. We cannot know for sure whether the problems in the surgical literature are worse than in other contexts, but we think they are because of the general underapplication of rigorous experimental design methods for clinical questions in surgery. Full-Text PDF Believability of clinical trials: A diagnostic testing perspectiveThe Journal of Thoracic and Cardiovascular SurgeryVol. 132Issue 2PreviewClinical trials are the medical community’s diagnostic tests. When a physician sends a patient for a conventional diagnostic test, he or she is asking whether a certain disease is likely to be present. Similarly, when the medical community designs and executes a clinical trial, it wants to know whether a certain treatment is likely to work. And just like a diagnostic test, a clinical trial has the potential for yielding an incorrect, erroneous result. Full-Text PDF" @default.
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