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- W2137712069 abstract "Results from randomized controlled trials (RCTs) can have an immediate impact on patient care. Accurate and complete reporting is essential to determine whether trial design, conduct, and analyses are scientifically creditable. Consolidated Standards of Reporting Trials (CONSORT) require explicit reporting of specific components of trial methodology necessary to allow readers to accurately assess trial validity (1–3). Trial information should also be informative, allowing readers to determine whether the results are able to be generalized to non-trial patients and whether the risk to benefit ratio of the intervention is medically acceptable. Although adherence to CONSORT guidelines allows reviewers, journal editors, and readers to judge the quality of trial methodology and validity of results, these guidelines do not necessarily ensure the reporting of sufficient information for quality application of treatment within the broad clinical community following trial publication. After reading the trial publication, the oncology care provider should be able to judge the credibility of the results and the risks and benefits and decide on whether to begin recommending the new treatment to patients within his or her practice. The need for clinicians to understand all trial details is especially important for trials of oncology therapeutics, which are often toxic and complex. Cancer treatment regimens may require combinations of drugs, radiation, and surgery applied in certain sequences and time frames. Treatment modifications, delays, and interruptions and supportive care measures that were specified within the protocol assure a degree of uniform application within the trial that might not be applied in broad clinical practice. Increased toxicities and reduced efficacy of new agents following trial publication may be partially explained by differences in patient populations, difference in treatment administration, and clinician experience (4). In this issue of the Journal, Duff et al. (5) describe an additional possible explanation for the lower effectiveness of treatments in clinical use relative to trial reports: a lack of description of the experimental treatment within the trial publication that might limit the replication of the protocol-specified trial intervention in clinical" @default.
- W2137712069 created "2016-06-24" @default.
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- W2137712069 date "2010-05-19" @default.
- W2137712069 modified "2023-09-25" @default.
- W2137712069 title "From Quality of Publication to Quality of Care: Translating Trials to Practice" @default.
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- W2137712069 doi "https://doi.org/10.1093/jnci/djq142" @default.
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