Evolution of Translational Omics Lessons Learned and the Path Forward (2012) / Chapter Skim
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Appendix D: Reporting Guidelines
Appendix D: Reporting Guidelines
Pages 289-300
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From page 289... ...
. In recent years, a number of international, multidisciplinary groups have developed reporting guidelines to improve the quality of published health research studies.
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THE NEED FOR MULTIPLE REPORTING GUIDELINES IN OMICS In the 2007 Institute of Medicine (IOM) report Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment, the committee noted that different sets of reporting guidelines would need to be developed depending on the technologies involved in a study, whether a single biomarker versus panels or patterns of biomarkers is being investigated, and the intended applications of the study.
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Each checklist item is explained and accompanied by published examples of good reporting, as well as relevant empirical evidence on the quality of reporting. The explanation and elaboration document highlights the REMARK profile, a suggested tabular format for summarizing key study details, and serves as a reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general.1 The current patchwork of reporting guidelines relevant to omics-based research may leave a number of gaps and overlaps in coverage (IOM, 2007)
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TABLE D-1 Reporting Standards Used in Omics Research 292 System Date Study Type Structure Adoption by Journals REMARK 2005 Tumor • 20-item checklist with the headings: A Mentioned in instructions to authors marker Introduction, Materials and Methods, Results, and from: prognostic Discussion • Clinical Cancer Research studies • Breast Cancer Research and Treatment • Journal of Clinical Oncology • Journal of the National Cancer Institute • Journal of Pathology CONSORT 2001 Randomized • 25-item checklist with the headings: Title, A CONSORT is endorsed by more than (updated in controlled Abstract, Introduction, Methods, Results, 50 percent of the core medical journals 2010) trials Discussion, and Other Information listed in the Abridged Index Medicus on • flow diagram depicting the passage of A PubMed participants through a trial (enrollment, intervention allocation, follow-up, and analysis)
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From page 293... ...
STARD 2003 Diagnostic • 25-item checklist with the headings: Title/ A More than 200 biomedical journals accuracy Abstract/Keywords, Introduction, Methods, encourage the use of the STARD statement Results, and Discussion in their instructions for authors • flow diagram depicting the method of A recruitment of patients or samples, the order of test execution, and the number of patients undergoing the test under evaluation and the reference test SOURCES: Bossuyt et al.
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Describe type of biological material used (including control samples) and methods of preservation and storage.
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17. Among reported results, provide estimated effects with confidence intervals from an analysis in which the marker and standard prognostic variables are included, regardless of their statistical significance.
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From page 296... ...
The first project of the Network was to identify all of the available guidelines for the reporting of health research studies and survey the reporting guideline authors to ascertain more information about their development methodology, dissemina tion and implementation strategies, problems they encountered, and impact of the guidelines. Investigators identified 37 reporting guidelines that met their inclu sion criteria, of which they received 30 survey responses (81 percent response rate)
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. However, a more recent analysis of the STARD reporting guideline found that the quality of reporting diagnostic accuracy studies has remained relatively constant (Wilczynski, 2008)
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instructions explicitly list the reporting guidelines that its authors must follow and also note that authors need to submit accompanying checklists and flowcharts in compliance with the guidelines. Its justification for this policy is "to improve BMJ papers' reporting and increase reviewers' understanding" of the elements that must be included in a report of a health research study (BMJ, 2011)
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2004. Missing covariate data within cancer prognostic studies: A review of current reporting and proposed guidelines.
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2008. Guidelines for reporting health research: The EQUATOR Network's survey of guideline authors.
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