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

Shanthi Sivendran · Kristina Braine Newport · Michael Horst · Adam Albert · Matthew D. Galsky

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Meta-analysis and systematic reviews Academic Writing and Publishing Academic Publishing and Open Access

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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References

2001The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials 2001The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration 2001The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials 2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement 2008CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration 2001Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.1999Accuracy of Data in Abstracts of Published Research Articles 2011Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial

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2020Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review 2021Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016

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