Introduction
What is new?
Key findings- •
The reporting quality of oncology trial abstracts shows suboptimal improvement even after the publication of Consolidated Standards of Reporting Trials (CONSORT) for Abstract guidelines.
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Trials published in high–impact factor journals (>20) demonstrated better reporting quality.
What this adds to what was known?- •
Studies evaluating the effect of CONSORT for Abstract guidelines in the reporting of oncology clinical trial abstracts are lacking. We identified inconsistencies and pattern of nonadherence in the methodological quality domains, which may conceal important problems in trial design or conduct and could seriously mislead a reader's interpretation of trial findings.
What is the implication and what should change now?- •
Improvements in the quality of oncology trial abstracts can be expected by adherence, on the part of the authors and the journal editors during peer review, to existing standards and guidelines as expressed by the CONSORT group. Thus, it is recommended that oncology journal editors should require and facilitate their authors and peer reviewers to use CONSORT for Abstract checklists to ensure reliable submission and peer review of these elements in the abstracts.
The Consolidated Standards of Reporting Trials (CONSORT) for Abstract guidelines were developed to improve the reporting quality of randomized controlled trial (RCT) abstracts [1]. RCTs are considered evidence of the highest grade in the hierarchy of research designs and represent the main source of current clinical guidelines [2]. RCT reports can have a powerful and immediate impact on patient care; therefore, accurate and complete reporting concerning design, conduct, analysis, and generalizability of the trial should be conveyed [3]. Interpretation of RCT results is difficult, if not impossible, with inadequate reports, resulting in biased results falsely being deemed reliable [4]. Specifically, inappropriate methods of creating and concealing random allocation, selective attrition, and faulty double blinding have the potential to bias the estimates of treatment effects in RCTs [5]. Although low reporting quality is not necessarily synonymous with low study quality, reporting needs to be improved [6] because adequate reporting is essential for the reader to evaluate how a clinical trial was conducted and judge its validity [7].
RCT abstracts should contain sufficient information about the trial to serve as an accurate record of its conduct and findings and should provide optimal information about the trial within the space constraints of the abstract format. Because the abstract is often the only substantive portion of an article read by consumers, authors must be vigilant that the abstracts precisely reflect the content of the article. However, previous studies underscore setbacks in the accuracy and quality of abstracts, including a deficit of information about the trial methodology and the robustness of the trial results [8], [9]. Thus, the International Committee of Medical Journal Editors emphasized that articles reporting clinical trials should contain abstracts that include the essential items identified by CONSORT [10].
Studies evaluating the effect of CONSORT for Abstract guidelines in the reporting of oncology clinical trials are lacking. Some previous studies have assessed RCT reporting quality in rare tumor subtypes such as brain tumors [11], Hodgkin's lymphoma [12], and sarcomas [13]. However, a systematic and comprehensive investigation of the abstracts of RCTs for all tumor types is lacking. A recent study that investigated the reporting quality of oncology RCTs using the 2001 CONSORT statement [14] determined that numerous CONSORT items, including the method of randomization, allocation concealment, details of blinding, and participant flow, remained unreported for many trials [15]. In the present study, we aimed to assess the overall reporting quality of oncology RCT abstracts published before and after the publication of the CONSORT for Abstract guidelines and to investigate trial characteristics associated with better reporting quality.