JAMA : the journal of the American Medical Association
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The CONSORT (Consolidated Standards of Reporting Trials) Statement, which includes a checklist and a flow diagram, is a guideline developed to help authors improve the reporting of the findings from randomized controlled trials. It was updated most recently in 2010. ⋯ In this article, we present an updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials, based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and provide illustrative examples and explanations for those items that differ from the main 2010 CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the reliability of their results and conclusions.
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Chronic venous disease, reviewed herein, is manifested by a spectrum of signs and symptoms, including cosmetic spider veins, asymptomatic varicosities, large painful varicose veins, edema, hyperpigmentation and lipodermatosclerosis of skin, and ulceration. However, there is no definitive stepwise progression from spider veins to ulcers and, in fact, severe skin complications of varicose veins, even when extensive, are not guaranteed. ⋯ She has had vein problems over the course of her life. Her varicose veins recurred after initial treatment, and she is now seeking guidance regarding her current treatment options.
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Clinical investigators are increasingly testing treatments that have the primary benefit of decreased burden or harms relative to an existing standard. The goal of the resulting randomized trials--called noninferiority trials--is to establish that the novel treatment's effectiveness is not substantially less than the existing standard. Conclusions from these trials are, however, based on noninferiority thresholds specified by authors whose judgments may not coincide with those of patients and clinicians. ⋯ Suboptimal administration of standard treatment or exclusive reliance on the analyze-as-randomized approach that is standard for conventional superiority trials may produce misleading results in noninferiority trials. Clinicians should judge whether the novel treatment's impact on effectiveness outcomes--the prime reason for wanting to prescribe it--is sufficiently close to that of standard treatment that they are comfortable substituting it for the existing standard. Trading off desirable and undesirable consequences is an individual decision: given the benefits of a novel treatment, some patients may perceive the uncertainty regarding a reduction in treatment effectiveness as acceptable while others may not.