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Structured Abstract

Objectives

Systematic reviews are currently used by only a minority of researchers to inform the design of research studies. This may lead to inefficient and potentially wasteful research. We aimed to develop a framework which clinical researchers can apply to existing systematic reviews in order to effectively inform the design of proposed new clinical research studies.

Data sources

Published frameworks or models designed to use results of systematic reviews or meta-analyses in new research study design.

Review methods

A multiphase iterative process was used to develop the framework. Phase 1 involved a focused literature search to identify existing frameworks and processes that have been proposed as methods to identify research gaps by systematic reviews. In phase 2, we convened a multidisciplinary group with varied expertise to develop a stepwise framework. In phase 3, we identified two systematic reviews and applied this framework to their results. Phase 4 invited external opinions from additional experts to further refine the framework.

Results

We developed a four-step framework designed to be useable by primary researchers: Step 1 involves clearly laying out the crucial design elements of the proposed study using PICOTS (populations, interventions, comparators, outcomes, timing, and setting) elements. Step 2 provides a simple method to identify an existing systematic review which is current, valid, and relevant enough to the proposed research study to inform its design. In Step 3, the details of the systematic review are examined to determine the extent to which it has already addressed the questions proposed by the new study, and uses the PICOTS elements of the primary studies included in the systematic review to modify the design of the proposed study. Finally, Step 4 establishes the need (or otherwise) for the proposed study, and prioritizes modifications to the research design.

Conclusions

The four-step framework proposes a practical method which can be used by clinical researchers who are not experts in systematic reviews to determine whether further research studies are needed and suggest ways that the primary literature identified by the systematic review can be used to modify the design of further research studies. Further research needs to determine how useful and practical this proposed framework is for researchers, and attempt to measure its value in modifying research designs and optimizing research efficiency.