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Supplemental Project to Assess the Transparency of Reporting Requirements: Omega-3 Fatty Acids and Cardiovascular Disease
Methods Research Reports
Investigators: Stacey Springs, PhD, Gaelen P Adam, MLIS, Valerie Langberg, ScM, Chris Halliday, ScM, and Thomas A Trikalinos, MD.
Author Information and AffiliationsStructured Abstract
Introduction:
Clinical trial registries that include prospective registration of study protocols and summarized results can inform the prevalence and impact of information bias. This methods report examines the feasibility and added utility of comprehensive searches of registries to supplement the evidence identified in an ongoing systematic review update on omega-3 fatty acids (n-3 FA) and CVD outcomes.
Data sources:
We conducted searches in ClinicalTrials.gov and the International Clinical Trials Registry Platform, using terms that matched those used in the original review database searches.
Results:
The original report included 98 studies (61 randomized controlled trials in 82 articles, and 37 longitudinal observational studies in 65 articles). We compared our registry search yield with our original report to identify studies: (1) registry record present, included in original review (26 studies, 4 with eligible results); we found that, in general, the agreement between the registry record and the published paper was good when the information was given in both. (2) Registry record present, not included in original review (43 studies); of these 23 were completed, 10 were ongoing, and 13 had unknown status. A single record yielded a new publication emanating from a study included in the original report. (3) No registry record, included in original review (72 studies); we posit that this is, in part, because many of the studies in the report predate the requirement to register trials.
Conclusions:
While we found that for this project, searching registry data added little to the evidence, one way in which conducting a registry search is of value to a systematic review project is in identifying ongoing research and gaps in knowledge. Several of the studies not found in the original review but identified through registry searches were unfinished or in progress at the time of the search. These studies should be taken in to account when evaluating the state of the literature and calling for future research.
Contents
- Preface
- Background and Objectives
- Methods
- Results
- Discussion
- References
- Appendix A. Search Strategies
- Appendix B. Inclusion criteria: Effects of Omega-3 Fatty Acids on Cardiovascular Disease
- Appendix C. Risk of Bias Criteria from the Original Report
- Appendix D. Excluded Studies
- Appendix E. Studies in Both the Report and Registry
Suggested citation:
Springs S, Adam GP, Langberg V, Halliday C, Trikalinos TA. Supplemental Project to Assess the Transparency of Reporting Requirements: Omega-3 Fatty Acids and Cardiovascular Disease. Methods Research Report. (Prepared by the Brown University Evidence-based Practice Center under Contract No. 290-2015-00002-I; 290-32004-T). AHRQ Publication No. 17-EHC019-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2017. www.effectivehealthcare.ahrq.gov/reports/final.cfm. DOI: https://doi.org/10.23970/AHRQEPCMETH3.
This report is based on research conducted by the Brown University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00002-I; 290-32004-T). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies may not be stated or implied.
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