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Published in: Trials 1/2015

Open Access 01-12-2015 | Research

Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies

Authors: Shanthi Sivendran, Kristina Newport, Michael Horst, Adam Albert, Matthew D. Galsky

Published in: Trials | Issue 1/2015

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Abstract

Background

Manuscript abstracts represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in abstracts as a basis for treatment decisions particularly when full-text articles are not accessible. In 2007, the Consolidated Standards of Reporting Trials (CONSORT) extension statement for abstracts provided a minimum list of elements that should be included in abstracts. In this study we evaluate the degree of adherence to these recommendations and accessibility of full text publications in oncology publications.

Methods

A systematic review of abstracts of randomized, controlled, phase III trials in metastatic solid malignancies published between January 2009 and December 2011 in PubMed, Medline, and Embase was completed. Abstracts were assigned a completeness score of 0–18 based on the number of CONSORT-recommended elements. Accessibility through open access was recorded.

Results

174 abstracts with data for 95,956 patients were reviewed. The median completeness score was 9 (range, 3–17). Open access to full text articles was available for 80 % of abstracts. The remaining 20 % (35 out of 174) had a median cost of 38 USD (range: $22–49.95). The least frequently reported elements were: trial design description (20 %), participant allocation method (13 %), blinding (24 %), trial enrollment status (22 %), registration and name of trial (26 %) and funding source (18 %). The most frequently reported elements were eligibility criteria (98 %), study interventions (100 %), and primary endpoint (87 %).

Conclusion

There is poor adherence to the CONSORT recommendations for abstract reporting in publications of randomized cancer clinical trials which could negatively impact clinical decision-making. Full-text articles are frequently available through open access.
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Metadata
Title
Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies
Authors
Shanthi Sivendran
Kristina Newport
Michael Horst
Adam Albert
Matthew D. Galsky
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0885-9

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