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Proposal 1540

Title of the Proposed Research

IMPROVING METHODS. Our research focus is to optimize the translation of clinical trial results into clinical practice.

Lead Researcher

Dr. Issa Dahabreh

Affiliation

Brown University

Funding Source

PCORI

Potential Conflicts of Interest

None

Data Sharing Agreement Date

16 September 2016

Lay Summary

Our research focus is to optimize the translation of clinical trial results into clinical practice. By leveraging advances in causal inference and considerable existing data resources we will achieve the following specific aims. Our first aim is to develop methods for assessing the applicability of RCTs and transporting causal effects from RCTs to target populations; describe methods for assessing the robustness of inferences based on these methods. Second, to evaluate the performance of methods developed in Aim 1 in simulation studies that will reflect real-world data. Third, to empirically assess the methods developed under Aims 1 and 2 in high-impact clinical topics (including the ALLHAT trial). Our methods will allow decision-makers to (1) statistically assess the applicability of trials to a target population; (2) “transport” trial results to patients seen in clinical practice; (3) apply trial results to specific patient subgroups in the broader target population.

Study Data Provided

Study GSK-AR1108888: FondaparinUx Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with Unstable Angina/Non ST segment elevation myocardial infarction (UA/NSTEMI) initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.