The Agency for Healthcare Research and Quality (AHRQ) commissioned a series of methods papers to describe and provisionally recommend methods for the Future Research Needs (FRN) projects and reports. Our paper proposes a method for composing the study design considerations portion of FRN reports; this portion discusses proposed research designs for addressing the high-priority research needs as determined by stakeholder opinion. Each proposed research design is accompanied by a discussion of advantages and disadvantages for using the approach. Here we present a framework based on a standard taxonomy for study designs and criteria for evaluating the appropriateness of a study design to address a particular research need. Criteria for evaluating each design include the advantages of the study design for producing a valid result; the resources needed and duration of the proposed study; the availability of data or ability to recruit; and ethical, legal, or social issues. The study design discussions are intended to be considerations and not prescriptive to researchers or funders. This framework is intended to help FRN project teams consistently apply criteria to determine which study design may be most appropriate for each research question, and to provide suggestions for the rationale and presentation of their design choices.

Contents

• Preface
• Acknowledgments
• Introduction
  • Comparative Effectiveness Research
  • Future Research Needs
  • The Future Research Needs Process
  • Scope of This Paper
• Role of Study Design Considerations Within Future Research Needs
• From Systematic Review to Study Design Considerations
• Common Terminology for Study Designs
• Criteria for Considering Study Designs
  • Advantages of Study Design for Producing a Valid Result
• Issues in the Application of the Framework to Future Research Needs Projects
  • Composition of the FRN Team
  • Timing of Study Design Application
  • Weighing Different Considerations in Study Designs
  • Sample Size Calculations
  • Format
  • Discussion of Study Designs Not Included in the Systematic Review
• Examples of Study Design Considerations
  • Example 1. Narrative/Bulleted Text
  • Example 2. Table
  • Example 3. Process or Methods Considerations
  • Example 4. Sample Size Calculations To Inform Feasibility of Future RCTs
• Conclusions
• References
• Appendixes
  • Appendix A. Taxonomy for Study Designs

Suggested citation:

Carey T, Sanders GD, Viswanathan M, Trikalinos TA, Kato E, Chang S. Framework for Considering Study Designs for Future Research Needs. Methods Future Research Needs Paper No. 8 (Prepared by the RTI–UNC Evidence-based Practice Center under Contract No. 290-2007-10056-I.) AHRQ Publication No. 12-EHC048-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on work conducted by the Research Triangle Institute International-University of North Carolina Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10056-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, 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.

The information in this report is intended to help health care researchers and funders of research make well informed decisions in designing and funding research and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of scientific judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical research and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances.

This report may be used, in whole or in part, as the basis for research design or funding opportunity announcements. AHRQ or the U.S. Department of Health and Human Services endorsement of such derivative products or actions may not be stated or implied.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

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