Researchers often seek guidance and tools to ensure that their planned studies can be developed and completed to meet the standards of high-quality clinical research. Members of the AAOS Evidence-Based Medicine Unit recognized this need and have created a set of tools to facilitate and encourage the conduct of high-quality research with a goal of establishing a stronger and more comprehensive evidence base for clinical practice guideline (CPG) recommendation and performance measure (PM) development.
Drawing on methodology and resources utilized in guideline development, the Research Roadmap (Fig. 1) seeks to give researchers insight to improve or self-assess their work, regardless of level of experience. The guides, checklists, calculators, and web links in the Roadmap are available for free on the AAOS website (www.aaos.org/ResearchRoadmap).
The Research Roadmap provides helpful materials for the following research areas:
Institutional Review Board (IRB) and Grant Funding. Many options for study approval and funding are available, but they are not always very organized or easy to find. The Research Roadmap provides a list of IRB and grant resources including public or private IRB and grant options/links, proposal and application guides, frequently asked questions, and government and organizational standards.
Planning a Study. Researchers at the beginning stages of study development can choose their study design (eg, intervention, prognostic, or diagnostic) from the Roadmap to download a PDF checklist of study components that are necessary to include for high-quality designs. This checklist is complemented by additional details for each section regarding potential risks of bias as well as examples of standard and discouraged methods.
Study Calculators. In addition to outcome measurement, these calculators offer implementation and design calculation tools for random number generation, power analysis, and sample size estimation. The outcome measurement tools focus on key data used for intervention, prognostic, and diagnostic studies including calculators for both continuous data (mean difference, variance, confidence limits, and significance) and dichotomous data (odds ratios, risk ratios, risk difference, variance, confidence limits, sensitivity, specificity, likelihood ratios, and significance).
Manuscript Preparation. Researchers who have completed their study and/or data collection can download the appropriate PDF formatted checklist for their design to ensure that all the necessary components of a high-quality study have been included. Additional details on each section regarding potential risks of bias as well as examples of standard and discouraged methods are provided as a reference if needed.
Journal Submission. A list of more than 70 peer-reviewed journals provides links directly to submission criteria. The list is laid out by specialty to help authors determine which journals may be best suited for a particular manuscript.
Study Quality Appraisal. Published authors and/or authors of a completed manuscript may want to evaluate the quality of their study to see how their methods and presentation match up to AAOS CPG standards. Users can choose their study design to open the appropriate web form with true/false questions assessing potential risks of bias in the methods. The form will automatically display an ultimate quality rank based on the accuracy of the responses provided, along with additional details regarding potential areas of bias for each question. These results can be easily printed or emailed to the author for future reference.
Responses from clinical professionals who have tried the Roadmap have been positive. "This is the first guide of its kind," said Ryan Leahy, DO, of Franciscan St. James Health. "The tools are very clear and concise yet comprehensive and user-friendly."
Frank Tenuto, MD, of Rush University Medical Center, commented: "Finally, a user-friendly guide for researchers to access everything they need in one location. This is a great way to make sure the research and body of the study are all inclusive. These resources are very well done, and I will definitely make use of them going forward."
The authors are staff members in the AAOS department of research, quality and scientific affairs.