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Suggested guidelines for developing a research project plan


As an example, the following research plan might have been used in the past to develop a research project on features predictive of difficult intubation:

RESEARCH QUESTION:

e.g. "Does degree of mouth opening predict ease of intubation?"


RELATED AREA OF CLINICAL "NEED":

e.g. "Difficult intubation is a potentially fatal anesthetic complication. The ability to predict difficult intubation may allow for proper preparation and decreased risk of adverse outcomes."


CURRENT KNOWLEDGE GAPS IN THIS AREA:

e.g. "At the time of writing, very little has been published about anatomical features predictive of difficult intubation..."


HYPOTHESIS TO BE TESTED:

e.g. "Based on preclinical anatomy studies, this project seeks to test the hypothesis that decreased mouth opening is predictive of difficult intubation."


PROPOSED STUDY DESIGN:

e.g. "We propose to prospectively evaluate 500 surgical patients. Prior to surgery, degree of mouth opening will be quantified. During laryngoscopy/intubation difficulty of intubation will be graded using a clinical scoring tool."


POSSIBLE PITFALLS, FEASIBILITY AND EXPECTED PROJECT TIMELINE:

e.g. "Our methods for quantifying mouth opening and scoring difficulty of intubation first need to be validated. It may be difficult to recruit 500 patients and complete the project during the span of one resident's training therefore, this will be a collaborative multicenter study. It is unclear whether 500 patients will provide the necessary statistical power to test this hypothesis. Based on an interim analysis after 250 patients, a subsequent sample size calculation will be performed and, if necessary, the number of study patients will be increased above 500."



   

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