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  • 标题:Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies
  • 本地全文:下载
  • 作者:Shanthi Sivendran ; Kristina Newport ; Michael Horst
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2015
  • 卷号:16
  • 期号:1
  • 页码:1
  • DOI:10.1186/s13063-015-0885-9
  • 语种:English
  • 出版社:BioMed Central
  • 摘要:Background Manuscript s represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in s 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 s provided a minimum list of elements that should be included in s. 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 s of randomized, controlled, phase III trials in metastatic solid malignancies published between January 2009 and December 2011 in PubMed, Medline, and Embase was completed. s were assigned a completeness score of 0–18 based on the number of CONSORT-recommended elements. Accessibility through open access was recorded. Results 174 s 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 s. 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 reporting in publications of randomized cancer clinical trials which could negatively impact clinical decision-making. Full-text articles are frequently available through open access.
  • 关键词:CONSORT ; Abstract ; Quality ; Cancer ; Clinical trials ; Open access
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