Reports of clinical trials: ethical aspects.

doi:10.1016/j.jtcvs.2006.03.042 iruvoipati and colleagues 1 have shown us glaring deficiencies in the rep ing of randomized controlled trials (RCTs) in the cardiothoracic surgery (CTS) literature. The CONSORT statement, a checklist and flowchart used n writing reports of RCTs, is a tool that can be used to improve RCT reports; it is ndorsed by most major medical journals but by none of the major cardiothoracic ournals. Why is this? One reason might be that RCTs are not as applicable to urgical as to medical disciplines. Indeed, the authors observe that RCTs are only alf as prevalent in our journals as they are in general medical journals, and herefore CTS journal editors might be less inclined to pay attention to quality of eporting of low-incidence articles. RCTs, the gold standard of clinical investigation, are less common in CTS ournals than in medical journals for several reasons. Surgical clinical trial protocols hat use no-treatment or placebo control groups are often not ethical, not desirable, r both. Double blinding is usually not practicable because the surgeon must know hat he or she is doing (although blinding of assessors and analysts can be done). oreover, groups of patients in need of specific operations are often small and not asily amenable to statistical analysis. Of greatest importance, however, is a special haracteristic of surgical procedures: they are associated with a learning curve and mall incremental improvements in technique that progressively improve outomes. Few of these limitations apply to drug trials and other medical inv ions, and therefore we should not find it surprising that RCTs are more frequent in edical than in surgical journals. Nevertheless, Tiruvoipati and colleagues 1 identified 62 RCTs in CTS journals 003. This is not a trivial number, and therefore perhaps it is time for CTS journals o look more closely at the quality of the reports they publish. Accurate and omplete reporting of relevant information arising from investigations benefits veryone: physicians-investigators because they learn what will benefit their paients and what will not; the human patients-subjects because of fulfillment of their xpectations that serving as experimental subjects will advance health care and erhaps directly benefit themselves and that the risks they have taken have not been asted; and future patients because they will be the beneficiaries of new information bout drugs, methods, or operations. Conversely, inaccurate and incomplete reportng of clinical investigations harms those same individuals and groups. Reporting of clinical investigations can be compromised in many ways. For xample, industrial sponsors might erect barriers to publication of unfavorable esults; investigators might design, execute, or analyze results of studies poorly or eport results selectively; and journal reviewers and editors might overlook errors nd deficiencies. Therefore the critical need for accurate and complete reporting of linical investigations places certain burdens on individuals and institutions: ● sponsors must allow investigators freedom to report without bias or undue influence whatever the investigator believes is relevant, whether positive or negative and whether beneficial or harmful to product marketing; ● investigators must analyze their results objectively and report all relevant information, including conclusions and recommendations that are justified by the data, without overreaching and without understating; ● peer reviewers should evaluate the clarity and completeness of the report and judge whether the conclusions and recommendations are justified by the data reported; and