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Supplemental Project To Assess the Transparency of Reporting Requirements: Tympanostomy Tubes in Children With Otitis Media
Methods Research Reports
Investigators: Gaelen P Adam, MLIS, Stacey Springs, PhD, Valerie Langberg, ScM, Chris Halliday, ScM, and Thomas A Trikalinos, MD.
Author Information and AffiliationsStructured Abstract
Introduction:
Despite efforts to spur pediatric research, there is a paucity of pediatric-specific research data available to guide clinical decisionmaking. Searching the grey literature improves the identification of evidence not found in the peer-reviewed literature and may prove particularly valuable for pediatric research synthesis. The objective of this methodology report is to examine the feasibility and additional utility—in terms of impact on risk of bias and strength of evidence assessments—of comprehensive searches of trials registries to supplement the evidence identified in an ongoing systematic review on tympanostomy tubes in children with otitis media conducted by the Brown Evidence-based Practice Center (EPC).
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:
Six studies were identified in both the registries and the original review. Overall the agreement for design, arm information, baselines, and results was very close, but prespecified outcomes in almost all of the records differed from the outcomes in the publications based on those records. Twenty studies were screened in via registry searches but not found in the original review. Two gave results, but we were unable to incorporate them in to the analysis, due to the fact that they had no statistical analyses. The results of these trials would not have changed our initial meta-analyses, risk of bias, or strength or evidence assessments. Seven of the records without results indicate studies with completion dates in the future or recent past. The information about these studies can be used to inform future research needs. We were able to find a registry record for only four of the 178 studies in the original review.
Conclusions:
This project yields limited evidence on the utility of searching ClinicalTrials.gov, because only six records were found that matched papers in the report, along with two others that yielded new results. Based on the evidence we found, there does not appear to be an impact on the conclusions or strength of evidence in the report of including records from ClinicalTrials.gov and ICTRP. One way in which conducting a registry search is of value to a systematic review project is in identifying ongoing research, as well as gaps in knowledge, and facilitating prioritization of future research to reduce redundancy.
Contents
Suggested citation:
Adam GP, Springs S, Langberg V, Halliday C, Trikalinos TA. Supplemental Project to Assess the Transparency of Reporting Requirements: Tympanostomy Tubes in Children With Otitis Media. 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-EHC018-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2017. www.effectivehealthcare.ahrq.gov/reports/final.cfm. DOI: https://doi.org/10.23970/AHRQEPCMETH2.
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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