Consultation at the beginning, planning stages of the project with a professional biostatistician is undoubtedly a wise investment for the clinician who does not have a working knowledge of statistics. Data analysis requires statistical expertise, and interpretation of findings requires clinical expertise.5 It is always important to bear in mind that statistical significance may or may not coincide with clinical significance.
Explore this issue:April 2008
The presentation of results will depend on the original motivation for the study; you may want to generate a report in layperson’s language for your patients, especially if the results demonstrate positive impact of an intervention on quality of life and/or activities of daily living. The ultimate goal of patient-reported outcomes assessment, however, is to evaluate and improve the effectiveness of the care process; linking outcome information to clinical process will identify opportunities for process improvement, meet and perhaps exceed patient expectations for satisfaction and improved health status, and contribute higher level evidence supporting the effectiveness of otolaryngology-head and neck surgery interventions to the literature.
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- Spilker B. Guide to Clinical Trials. New York: Raven Press, 1991, p. 87.
- Norman GR, Streiner DL. PDQ Statistics (3rd ed.) Hamilton, Ontario: BC Decker, 2003.
- Davies AR, Doyle MAT, Lansky D, Rutt W, et al. Outcomes assessment in clinical settings: A consensus statement on principles and best practices in project management. J Quality Improvement 1994;20(1):5-16.
- Stone J. Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators. Cumberland, MD: Mountainside MD Press, 2006.
- Davies et al., op cit.
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