Does the administration of a outcomes-based decision aid during pre-operative consultation

improve patient’s core outcome set scores following oral cancer reconstructive surgery?
Background:
A Framework to Improve Surgeon Communication in High-Stakes Surgical Decisions: Best Case/Worst Case – LJ Taylor (2017)
Described outcomes rather than discrete procedural risks + involved patients and families in deliberation
Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial – ML Schwarze (2019)
Null effect noted from question intervention to help
Surgery Hurts: Characterizing the Experience of Pain in Surgical Patients as Witnessed by Medical Students. – TJ Zens (2019)
Interesting qualitative study on the disconnect b/t surgeons and their ability to understand patient pain
Decision aids for people facing health treatment or screening decisions – DL Stacey (2017)
1) timing (homework vs during consultation) didn’t matter, 2) they helped
Design
2) Make the model / database and develop a patient-centered decision aid
3) Administer the aid during pre-op visit.
4) Measure core outcome sets at 1 mo and 1 year f/u visits
Relevancy of this research question:
• In the world of “informed consent”, surgeons traditionally rely on disclosure of discrete procedural complications(1) aided by robust risk calculators.(2,3)
• Poor communication can lead to “poorly informed” consent
• Best Case/Worst Case framework helped in acute settings
Research Design

• Core outcome measures – asking pts what matters to them

• Impact trees – possible intervention

• Is the research design appropriate to answer the research question?

• What methods/methodologies will be used in this protocol?
• What techniques are being considered to analyze the data?
• What are the reasons for choosing the above methodology and data
analysis techniques?